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QA Manager
53786 Madison, Wisconsin
Public Consulting Group
Posted 1 day ago
Job Viewed
Job Description
Public Consulting Group LLC (PCG) is a leading public sector solutions implementation and operations improvement firm that partners with health, education, and human services agencies to improve lives. Founded in 1986, PCG employs approximately 2,000 professionals throughout the U.S.-all committed to delivering solutions that change lives for the better. The firm is a member of a family of companies with experience in all 50 states, and clients in three Canadian provinces and Europe. PCG offers clients a multidisciplinary approach to meet challenges, pursue opportunities, and serve constituents across the public sector. To learn more, visit .
PCG Health team helps our clients meet the complex financial, regulatory, and operational challenges of today's changing health care landscape, so they can provide the best care, most effectively, to those they serve. Our in-depth programmatic knowledge and regulatory expertise help state and municipal health agencies respond to regulatory change, improve access to health care, maximize program revenue, improve business processes, and achieve regulatory compliance.
Services:
+ Third Party Administrator Services
+ Enhance Health and Public Safety Services
+ Claims Processing Services and Solutions
+ Consulting and Advisory Services
+ Cost Allocation Plans and Time Studies
+ Cost Settlement and Supplemental Payment Strategies
+ Healthcare Access and Markets
A Test Leader oversees the testing process, developing test strategies and plans, guiding a team of testers, and collaborating with development teams to ensure software and product quality. Key responsibilities include designing tests, documenting and tracking defects, providing leadership and guidance to the team, and communicating testing progress to stakeholders to ensure high-quality product delivery.
Key Responsibilities
Test Planning & Strategy:
Develop comprehensive test strategies and plans, defining the scope, objectives, and required techniques for the testing process.
Team Leadership:
Lead, mentor, and support the testing team, setting goals, providing guidance, and managing their performance.
Test Execution & Analysis:
Design and oversee the execution of test cases, both manual and automated, to identify software defects and analyze test results to identify issues.
Defect Management:
Document, track, and report defects using bug tracking systems, and work with developers to ensure issues are resolved effectively.
Collaboration:
Work closely with cross-functional teams, including developers, project managers, and business analysts, to ensure quality throughout the development lifecycle.
Reporting:
Prepare and deliver regular status reports to project management and other stakeholders, detailing testing progress and key quality metrics.
Process Improvement:
Continuously evaluate and improve testing processes and methodologies to enhance efficiency and effectiveness.
**Duties and Responsibilities**
+ Provides leadership, management, and direction to the Quality Assurance Analyst team.
+ Leads and manages department providing oversight on operations, schedules and deliverables.
+ Regularly assesses staffing needs, identify areas of team or individual development and implement a plan to address personal or technical growth.
+ Interacts with project managers and development teams to develop a strong understanding of the project and testing objectives.
+ Designs and creates test conditions and scripts to address business and technical use cases.
+ Conducts internal reviews on a periodic basis to verify that staff are adhering to the policies and procedures and internal controls that are in place
+ Analyzes, develops, and executes test data validation strategies to validate reports and data
+ Manages spec reviews and requirements' definitions in order to detect measurable requirements for testing (completeness and accuracy)
**Required Skills**
+ Proficiency designing, developing and executing functional testing deliverables
+ Excellent interpersonal skills with the ability to establish relationships with co-workers and all levels of management
+ Strong analytical and problem solving skills
+ Excellent planning and organizational skills to balance and prioritize work
+ Working knowledge of performance testing for web applications
+ Experienced in understanding products and processes and break them down into testing components
**Qualifications**
+ Bachelor's degree in Computer Science or relevant technical discipline; Masters preferred
+ 7+ years relevant QA experience, 1 - 2 years supervisory/management experience
**Working Conditions**
+ Office Setting
**The above is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities or skills of personnel so classified.**
**PCG does not sponsor newly hired foreign national workers for work authorization, including H-1B sponsorship** .
#LI
#LI-LR1
#LI-remote
**Compensation:**
Compensation for roles at Public Consulting Group varies depending on a wide array of factors including, but not limited to, the specific office location, role, skill set, and level of experience. As required by applicable law, PCG provides a reasonable range of compensation for this role. In addition, PCG provides a range of benefits for this role, including medical and dental care benefits, 401k, PTO, parental leave, bereavement leave.
**As required by applicable law, PCG provides the following reasonable range of compensation for this role: $85,900-$95,900. In addition, PCG provides a range of benefits for this role, including medical and dental care benefits, 401k, PTO, parental leave, bereavement leave.**
PCG does not sponsor newly hired foreign national workers for work authorization, including H-1B sponsorship.
**EEO Statement**
Public Consulting Group is an Equal Opportunity Employer dedicated to celebrating diversity and intentionally creating a culture of inclusion. We believe that we work best when our employees feel empowered and accepted, and that starts by honoring each of our unique life experiences. At PCG, all aspects of employment regarding recruitment, hiring, training, promotion, compensation, benefits, transfers, layoffs, return from layoff, company-sponsored training, education, and social and recreational programs are based on merit, business needs, job requirements, and individual qualifications. We do not discriminate on the basis of race, color, religion or belief, national, social, or ethnic origin, sex, gender identity and/or expression, age, physical, mental, or sensory disability, sexual orientation, marital, civil union, or domestic partnership status, past or present military service, citizenship status, family medical history or genetic information, family or parental status, or any other status protected under federal, state, or local law. PCG will not tolerate discrimination or harassment based on any of these characteristics. PCG believes in health, equality, and prosperity for everyone so we can succeed in changing the ways the public sector, including health, education, technology and human services industries, work.
Public Consulting Group is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, or status as a qualified individual with a disability. VEVRAA Federal Contractor.
PCG Health team helps our clients meet the complex financial, regulatory, and operational challenges of today's changing health care landscape, so they can provide the best care, most effectively, to those they serve. Our in-depth programmatic knowledge and regulatory expertise help state and municipal health agencies respond to regulatory change, improve access to health care, maximize program revenue, improve business processes, and achieve regulatory compliance.
Services:
+ Third Party Administrator Services
+ Enhance Health and Public Safety Services
+ Claims Processing Services and Solutions
+ Consulting and Advisory Services
+ Cost Allocation Plans and Time Studies
+ Cost Settlement and Supplemental Payment Strategies
+ Healthcare Access and Markets
A Test Leader oversees the testing process, developing test strategies and plans, guiding a team of testers, and collaborating with development teams to ensure software and product quality. Key responsibilities include designing tests, documenting and tracking defects, providing leadership and guidance to the team, and communicating testing progress to stakeholders to ensure high-quality product delivery.
Key Responsibilities
Test Planning & Strategy:
Develop comprehensive test strategies and plans, defining the scope, objectives, and required techniques for the testing process.
Team Leadership:
Lead, mentor, and support the testing team, setting goals, providing guidance, and managing their performance.
Test Execution & Analysis:
Design and oversee the execution of test cases, both manual and automated, to identify software defects and analyze test results to identify issues.
Defect Management:
Document, track, and report defects using bug tracking systems, and work with developers to ensure issues are resolved effectively.
Collaboration:
Work closely with cross-functional teams, including developers, project managers, and business analysts, to ensure quality throughout the development lifecycle.
Reporting:
Prepare and deliver regular status reports to project management and other stakeholders, detailing testing progress and key quality metrics.
Process Improvement:
Continuously evaluate and improve testing processes and methodologies to enhance efficiency and effectiveness.
**Duties and Responsibilities**
+ Provides leadership, management, and direction to the Quality Assurance Analyst team.
+ Leads and manages department providing oversight on operations, schedules and deliverables.
+ Regularly assesses staffing needs, identify areas of team or individual development and implement a plan to address personal or technical growth.
+ Interacts with project managers and development teams to develop a strong understanding of the project and testing objectives.
+ Designs and creates test conditions and scripts to address business and technical use cases.
+ Conducts internal reviews on a periodic basis to verify that staff are adhering to the policies and procedures and internal controls that are in place
+ Analyzes, develops, and executes test data validation strategies to validate reports and data
+ Manages spec reviews and requirements' definitions in order to detect measurable requirements for testing (completeness and accuracy)
**Required Skills**
+ Proficiency designing, developing and executing functional testing deliverables
+ Excellent interpersonal skills with the ability to establish relationships with co-workers and all levels of management
+ Strong analytical and problem solving skills
+ Excellent planning and organizational skills to balance and prioritize work
+ Working knowledge of performance testing for web applications
+ Experienced in understanding products and processes and break them down into testing components
**Qualifications**
+ Bachelor's degree in Computer Science or relevant technical discipline; Masters preferred
+ 7+ years relevant QA experience, 1 - 2 years supervisory/management experience
**Working Conditions**
+ Office Setting
**The above is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities or skills of personnel so classified.**
**PCG does not sponsor newly hired foreign national workers for work authorization, including H-1B sponsorship** .
#LI
#LI-LR1
#LI-remote
**Compensation:**
Compensation for roles at Public Consulting Group varies depending on a wide array of factors including, but not limited to, the specific office location, role, skill set, and level of experience. As required by applicable law, PCG provides a reasonable range of compensation for this role. In addition, PCG provides a range of benefits for this role, including medical and dental care benefits, 401k, PTO, parental leave, bereavement leave.
**As required by applicable law, PCG provides the following reasonable range of compensation for this role: $85,900-$95,900. In addition, PCG provides a range of benefits for this role, including medical and dental care benefits, 401k, PTO, parental leave, bereavement leave.**
PCG does not sponsor newly hired foreign national workers for work authorization, including H-1B sponsorship.
**EEO Statement**
Public Consulting Group is an Equal Opportunity Employer dedicated to celebrating diversity and intentionally creating a culture of inclusion. We believe that we work best when our employees feel empowered and accepted, and that starts by honoring each of our unique life experiences. At PCG, all aspects of employment regarding recruitment, hiring, training, promotion, compensation, benefits, transfers, layoffs, return from layoff, company-sponsored training, education, and social and recreational programs are based on merit, business needs, job requirements, and individual qualifications. We do not discriminate on the basis of race, color, religion or belief, national, social, or ethnic origin, sex, gender identity and/or expression, age, physical, mental, or sensory disability, sexual orientation, marital, civil union, or domestic partnership status, past or present military service, citizenship status, family medical history or genetic information, family or parental status, or any other status protected under federal, state, or local law. PCG will not tolerate discrimination or harassment based on any of these characteristics. PCG believes in health, equality, and prosperity for everyone so we can succeed in changing the ways the public sector, including health, education, technology and human services industries, work.
Public Consulting Group is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, protected veteran status, or status as a qualified individual with a disability. VEVRAA Federal Contractor.
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Sr. QA Manager
53786 Madison, Wisconsin
PCI Pharma Services
Posted 9 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility. In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Provides quality oversight of manufacturing activities on a day-to-day basis.
+ Review, develop, and improve quality system procedures, specifications, and test methods.
+ Provide status reports, including relevant quality metrics and participates in the management review process.
+ Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
+ Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
+ Serve as QA representative to cross functional project teams such as process improvement.
+ Perform risk assessments to comply with internal procedures and external guidelines.
+ Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
+ Ensures site readiness for regulatory inspections, client audits, and internal audits.
+ Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
+ Assist with internal audits, client audits as well as supplier audits as needed. Review and approve supplier documents requiring Quality approval.
+ Interface with internal and external customers to address any documentation and compliance concerns.
+ Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures.
+ Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business's unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
+ May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs.
+ Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND PROFESSIONAL EXPERIENCE
+ Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required. ASQ certification preferred. ASQ certification preferred.
+ Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production. Minimum of 2 years of management responsibility preferred.
+ A minimum of 8 years of overall experience in biopharmaceutical quality
+ Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
+ Experience performing RCA, technical writing, and working with quality related investigations.
+ Knowledge of laboratory and production equipment and IQ/OQ/PQ
+ Knowledge of US and EU cGMP regulations and guidance
+ Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
+ Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release.
+ Knowledge in Operational Excellence and Continuous Improvement is highly desirable.
+ Experience in building and growing an organization into a high-performance team.
+ Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
PERSONAL SKILLS & COMPETENCIES
+ Exceptional organizational skills
+ Ability to make risk-based decisions and resolve issues with minimal guidance.
+ Excellent interpersonal skills and the ability to communicate well orally and in writing.
+ Proficiency in MS Office including Word, Excel, Access, and Visio
+ Ability to lead people in a dynamic, fast-paced work environment.
+ Honesty, integrity, respect, and courtesy with all colleagues
+ Creative with the ability to work with minimal supervision and balanced with independent thinking.
+ Resilient through operational and organizational change
+ Demonstrated leadership, interpersonal, communication, and motivation skills.
+ Well-practiced in exercising sound judgment in decision-making
+ Demonstrated multitasking and organization skills.
+ Past experience where one was required to work in a team-based environment with a diverse group of people. Previous work responsibility, which required a high degree of attention to detail.
#LI-LL1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility. In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ Provides quality oversight of manufacturing activities on a day-to-day basis.
+ Review, develop, and improve quality system procedures, specifications, and test methods.
+ Provide status reports, including relevant quality metrics and participates in the management review process.
+ Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
+ Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
+ Serve as QA representative to cross functional project teams such as process improvement.
+ Perform risk assessments to comply with internal procedures and external guidelines.
+ Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
+ Ensures site readiness for regulatory inspections, client audits, and internal audits.
+ Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
+ Assist with internal audits, client audits as well as supplier audits as needed. Review and approve supplier documents requiring Quality approval.
+ Interface with internal and external customers to address any documentation and compliance concerns.
+ Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures.
+ Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business's unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
+ May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs.
+ Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND PROFESSIONAL EXPERIENCE
+ Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required. ASQ certification preferred. ASQ certification preferred.
+ Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production. Minimum of 2 years of management responsibility preferred.
+ A minimum of 8 years of overall experience in biopharmaceutical quality
+ Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
+ Experience performing RCA, technical writing, and working with quality related investigations.
+ Knowledge of laboratory and production equipment and IQ/OQ/PQ
+ Knowledge of US and EU cGMP regulations and guidance
+ Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
+ Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release.
+ Knowledge in Operational Excellence and Continuous Improvement is highly desirable.
+ Experience in building and growing an organization into a high-performance team.
+ Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
PERSONAL SKILLS & COMPETENCIES
+ Exceptional organizational skills
+ Ability to make risk-based decisions and resolve issues with minimal guidance.
+ Excellent interpersonal skills and the ability to communicate well orally and in writing.
+ Proficiency in MS Office including Word, Excel, Access, and Visio
+ Ability to lead people in a dynamic, fast-paced work environment.
+ Honesty, integrity, respect, and courtesy with all colleagues
+ Creative with the ability to work with minimal supervision and balanced with independent thinking.
+ Resilient through operational and organizational change
+ Demonstrated leadership, interpersonal, communication, and motivation skills.
+ Well-practiced in exercising sound judgment in decision-making
+ Demonstrated multitasking and organization skills.
+ Past experience where one was required to work in a team-based environment with a diverse group of people. Previous work responsibility, which required a high degree of attention to detail.
#LI-LL1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
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1
QA Audit Manager
53786 Madison, Wisconsin
Datavant
Posted 9 days ago
Job Viewed
Job Description
Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format.
Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
We are seeking a QA Audit Manager to lead Datavant's Quality Assurance Audit function. This role is pivotal in ensuring operational effectiveness, regulatory compliance, and continuous process improvement across our audit operations. The QA Audit Manager provides day-to-day leadership, oversight, and mentorship to the QA team, driving professional development and team accountability. The QA Audit teams currently oversee digital fulfillment, the quality portion of the new-hire DHISC training program, and site- and processor-level feedback. By centralizing responsibility under an experienced leader, this role strengthens team performance and accelerates the establishment of a scalable, high-impact quality assurance framework.
**What You Will Do:**
+ Oversee audits of request and fulfillment processes to ensure compliance with state and federal laws, as well as Standard Operating Procedures (SOPs).
+ Identify workflow issues and trends in errors or delays, report findings, and recommend corrective actions.
+ Maintain and update audit tools, as well as detailed documentation of audit results and corrective measures.
+ Lead a team performing specialized site-specific and process-specific audits as needed.
+ Collaborate with operational leadership, training, compliance, and cross-functional partners to address trends, close knowledge gaps, and build tools to strengthen performance.
+ Recommend and support implementation of process improvements to increase efficiency and accuracy.
+ Ensure compliance with HIPAA, HITECH, and other regulations regarding PHI handling, and monitor adherence to client SLAs.
+ Provide direct leadership to the QA team, including performance management, training, feedback, coaching, and professional development.
+ Facilitate team meetings, calibration audits, and 1:1s to build accountability, engagement, and culture.
+ Up to 10% travel, as needed.
+ You will also be expected to support onboarding of new QA staff, deliver regular audit-based coaching, and contribute to strengthening Datavant's overall quality framework.
**What a Typical Day Looks Like**
In this role, you can expect to:
+ Collaborate cross-functionally with operations, compliance, training, and data teams.
+ Manage team responsibilities while providing coaching and day-to-day support.
+ Analyze audit results and trends to support leadership decisions.
+ Facilitate team meetings, individual coaching sessions, and professional development opportunities.
**What You Need to Succeed:**
+ Minimum 5 years of progressive leadership experience, preferably in healthcare operations, quality assurance, or related functions.
+ At least 2 years of experience in medical records management, release of information (ROI), or health information operations; Datavant experience preferred.
+ 2+ years in quality assurance or auditing, with demonstrated ability to evaluate processes, identify gaps, and implement corrective actions.
+ High School Diploma required; Associate's or Bachelor's degree in Health Information Management, Healthcare Administration, or related field strongly preferred.
+ Strong knowledge of HIPAA, HITECH, and PHI handling standards.
+ Previous experience managing payroll, scheduling, and workforce administration.
+ Excellent leadership, coaching, communication, and problem-solving skills.
+ Proficiency with EHR systems, audit tools, Microsoft Office Suite; request tracking tool experience strongly preferred.
**What Helps You Stand Out:**
+ Advanced certification in quality, compliance, or health information management (e.g., RHIT, RHIA, CHPS, Six Sigma).
+ Lean or Six Sigma certification with proven process improvement success.
+ Experience with dashboard-building or data analytics to support audit functions.
+ Strong history of building engaged, high-performing teams in fast-paced environments.
We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services.
The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job.
The estimated total cash compensation range for this role is:
$94,000-$102,000 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here ( . Know Your Rights ( , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, ( by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here ( . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy ( .
Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
We are seeking a QA Audit Manager to lead Datavant's Quality Assurance Audit function. This role is pivotal in ensuring operational effectiveness, regulatory compliance, and continuous process improvement across our audit operations. The QA Audit Manager provides day-to-day leadership, oversight, and mentorship to the QA team, driving professional development and team accountability. The QA Audit teams currently oversee digital fulfillment, the quality portion of the new-hire DHISC training program, and site- and processor-level feedback. By centralizing responsibility under an experienced leader, this role strengthens team performance and accelerates the establishment of a scalable, high-impact quality assurance framework.
**What You Will Do:**
+ Oversee audits of request and fulfillment processes to ensure compliance with state and federal laws, as well as Standard Operating Procedures (SOPs).
+ Identify workflow issues and trends in errors or delays, report findings, and recommend corrective actions.
+ Maintain and update audit tools, as well as detailed documentation of audit results and corrective measures.
+ Lead a team performing specialized site-specific and process-specific audits as needed.
+ Collaborate with operational leadership, training, compliance, and cross-functional partners to address trends, close knowledge gaps, and build tools to strengthen performance.
+ Recommend and support implementation of process improvements to increase efficiency and accuracy.
+ Ensure compliance with HIPAA, HITECH, and other regulations regarding PHI handling, and monitor adherence to client SLAs.
+ Provide direct leadership to the QA team, including performance management, training, feedback, coaching, and professional development.
+ Facilitate team meetings, calibration audits, and 1:1s to build accountability, engagement, and culture.
+ Up to 10% travel, as needed.
+ You will also be expected to support onboarding of new QA staff, deliver regular audit-based coaching, and contribute to strengthening Datavant's overall quality framework.
**What a Typical Day Looks Like**
In this role, you can expect to:
+ Collaborate cross-functionally with operations, compliance, training, and data teams.
+ Manage team responsibilities while providing coaching and day-to-day support.
+ Analyze audit results and trends to support leadership decisions.
+ Facilitate team meetings, individual coaching sessions, and professional development opportunities.
**What You Need to Succeed:**
+ Minimum 5 years of progressive leadership experience, preferably in healthcare operations, quality assurance, or related functions.
+ At least 2 years of experience in medical records management, release of information (ROI), or health information operations; Datavant experience preferred.
+ 2+ years in quality assurance or auditing, with demonstrated ability to evaluate processes, identify gaps, and implement corrective actions.
+ High School Diploma required; Associate's or Bachelor's degree in Health Information Management, Healthcare Administration, or related field strongly preferred.
+ Strong knowledge of HIPAA, HITECH, and PHI handling standards.
+ Previous experience managing payroll, scheduling, and workforce administration.
+ Excellent leadership, coaching, communication, and problem-solving skills.
+ Proficiency with EHR systems, audit tools, Microsoft Office Suite; request tracking tool experience strongly preferred.
**What Helps You Stand Out:**
+ Advanced certification in quality, compliance, or health information management (e.g., RHIT, RHIA, CHPS, Six Sigma).
+ Lean or Six Sigma certification with proven process improvement success.
+ Experience with dashboard-building or data analytics to support audit functions.
+ Strong history of building engaged, high-performing teams in fast-paced environments.
We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services.
The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job.
The estimated total cash compensation range for this role is:
$94,000-$102,000 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here ( . Know Your Rights ( , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, ( by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here ( . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy ( .
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2
Director - Quality Control
53786 Madison, Wisconsin
Catalent Pharma Solutions
Posted 1 day ago
Job Viewed
Job Description
**Director, Quality Control**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
+ Other duties as assigned.
**The Candidate**
+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
+ 6+ years of leadership experience required.
+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
+ Ability to communicate complex technical information to non-technical audiences.
+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
**Why You Should Join Catalent**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match and Paid Time Off accrual
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
+ Other duties as assigned.
**The Candidate**
+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
+ 6+ years of leadership experience required.
+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
+ Ability to communicate complex technical information to non-technical audiences.
+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
**Why You Should Join Catalent**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match and Paid Time Off accrual
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
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3
Quality Control Analyst
53786 Madison, Wisconsin
Actalent
Posted 1 day ago
Job Viewed
Job Description
Job Title: Temporary Quality Control Analyst
Job Description
The PCR Analyst will perform routine testing support and project support. This includes qPCR testing with a 7-hour turnaround time. The role requires teamwork to manage sample processing, with new samples arriving every 8 hours. The analyst will conduct in-process testing on raw materials, typically from pig origin, and finished product testing on pancreatin powder. Responsibilities also include contaminant monitoring, environmental monitoring, instrument calibration and maintenance, inventory management, and reagent preparation. Training will be provided on validation tasks, including basic centrifuges, spectrophotometers, and liquid handler robots, as well as software programming, lab space validation, and method drafting.
Responsibilities
+ Perform qPCR testing with a 7-hour turnaround time.
+ Conduct in-process testing on raw materials and finished product testing on pancreatin powder.
+ Perform contaminant monitoring and positive control environmental monitoring.
+ Calibrate and maintain instruments.
+ Manage inventory and prepare reagents.
+ Undergo training for validation tasks including centrifuges, spectrophotometers, and liquid handler robots.
+ Validate lab spaces and draft methods.
+ Run speciation assays to identify and quantify different species within a sample.
Essential Skills
+ Experience with PCR, QC, testing, method development, and quality control.
+ Knowledge of GMP, biology, pharmaceutical processes, and environmental monitoring.
+ Familiarity with FDA regulations, molecular biology, microbiology, and assay procedures.
+ Bachelor's degree or above in Microbiology or related discipline preferred.
+ 2+ years of PCR/Micro Lab experience preferred for Associate QC Analyst.
+ 5+ years of experience with GMP preferred for Sr QC Analyst.
Work Environment
This is a 12 month contract role operating on a 3rd shift schedule from Monday to Thursday, 9 PM to 7 AM, with a shift differential of $3.50/hr. The position is based in a brand new lab set to open in March 2025. The team comprises three members per shift, and the work environment is described as laid-back, driven, and hardworking. Initial training will occur on 1st shift for the first few weeks, followed by a transition to the assigned shift.
Pay and Benefits
The pay range for this position is $2.00 - 36.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Madison,WI.
Application Deadline
This position is anticipated to close on Nov 5, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Job Description
The PCR Analyst will perform routine testing support and project support. This includes qPCR testing with a 7-hour turnaround time. The role requires teamwork to manage sample processing, with new samples arriving every 8 hours. The analyst will conduct in-process testing on raw materials, typically from pig origin, and finished product testing on pancreatin powder. Responsibilities also include contaminant monitoring, environmental monitoring, instrument calibration and maintenance, inventory management, and reagent preparation. Training will be provided on validation tasks, including basic centrifuges, spectrophotometers, and liquid handler robots, as well as software programming, lab space validation, and method drafting.
Responsibilities
+ Perform qPCR testing with a 7-hour turnaround time.
+ Conduct in-process testing on raw materials and finished product testing on pancreatin powder.
+ Perform contaminant monitoring and positive control environmental monitoring.
+ Calibrate and maintain instruments.
+ Manage inventory and prepare reagents.
+ Undergo training for validation tasks including centrifuges, spectrophotometers, and liquid handler robots.
+ Validate lab spaces and draft methods.
+ Run speciation assays to identify and quantify different species within a sample.
Essential Skills
+ Experience with PCR, QC, testing, method development, and quality control.
+ Knowledge of GMP, biology, pharmaceutical processes, and environmental monitoring.
+ Familiarity with FDA regulations, molecular biology, microbiology, and assay procedures.
+ Bachelor's degree or above in Microbiology or related discipline preferred.
+ 2+ years of PCR/Micro Lab experience preferred for Associate QC Analyst.
+ 5+ years of experience with GMP preferred for Sr QC Analyst.
Work Environment
This is a 12 month contract role operating on a 3rd shift schedule from Monday to Thursday, 9 PM to 7 AM, with a shift differential of $3.50/hr. The position is based in a brand new lab set to open in March 2025. The team comprises three members per shift, and the work environment is described as laid-back, driven, and hardworking. Initial training will occur on 1st shift for the first few weeks, followed by a transition to the assigned shift.
Pay and Benefits
The pay range for this position is $2.00 - 36.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Madison,WI.
Application Deadline
This position is anticipated to close on Nov 5, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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4
Sr Coordinator, Quality Control
53786 Madison, Wisconsin
Cardinal Health
Posted 7 days ago
Job Viewed
Job Description
Cardinal Health Sonexus Access and Patient Support helps specialty pharmaceutical manufacturers remove barriers to care so that patients can access, afford and remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer and hub services allows us to deliver best-in-class solutions-driving brand and patient markers of success. We're continuously integrating advanced and emerging technologies to streamline patient onboarding, qualification, and adherence. Our non-commercial specialty pharmacy is centralized at our custom-designed facility outside of Dallas, Texas, empowering manufacturers to rethink the reach and impact of their products.
**Together, we can get life-changing therapies to patients who need them-faster.**
**What Performance Monitoring contributes to Cardinal Health:**
Performance Monitoring is responsible for establishing, maintaining, and enhancing customer business through contract administration, customer orders, and problem resolution. Performance Monitoring is responsible for monitoring, analyzing, and reviewing customer contact quality.
**Responsibilities:**
+ Evaluate calls and cases to assess performance based on a standard set of criteria, providing constructive feedback and recognition to employees to ensure high performance and continuous improvement.
+ Accurately score transactions to gauge employee's quality performance based on organizational and departmental policies and requirements.
+ Monitor and evaluate team performance, whether voice or non-voice, of assigned entity and team, ensuring adherence to company quality standards, and compliance with industry regulations.
+ Track and report any trends from the customer experience that can be improved or celebrated.
+ Analyze and provide weekly & monthly trend analysis to leadership.
+ Provide support to leadership by participating in and hosting internal/external client calibration sessions.
+ Engage in and lead projects to promote quality enhancements and/or broaden services for the team.
+ Maintain a comprehensive understanding of quality systems and methodologies as well as knowledge of applicable regulations, standards, and operating procedures.
+ Conduct investigations/root cause analysis and formulate corrective action recommendations.
+ Show an understanding of the program requirements and be capable of conducting gap assessments based on those requirements.
+ Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures.
+ Collaborate across various functions, interpret requirements, educate and influence others regarding those requirements.
+ Identify training needs or potential disciplinary actions which will be reported to leadership.
+ Build strong customer relationships and deliver customer-centric solutions.
+ Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement.
+ Develop strategic alliances and cooperate with stakeholders to achieve mutual goals.
+ Demonstrate resourcefulness by adeptly securing and efficiently deploying resources.
+ Analyze complex and high-quality, sometimes contradictory, information to solve problems effectively.
+ Hold oneself and others accountable for meeting commitments and objectives.
+ Exhibit situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations.
+ Create and implement diverse communication strategies that clearly address the specific requirements of various target audiences.
**Qualifications:**
+ HS Diploma, GED or technical certification in related field or equivalent experience, preferred. Diploma or degree in relevant field desirable.
+ 3+ years' call quality audit experience strongly preferred.
+ 3+ years' experience in a patient support program or hub field would be an asset.
+ Adverse Event reporting and reconciliation experience strongly preferred.
+ Data collection and trend reporting experience is essential for this role.
+ Proficiency in MS Office applications required - Outlook, Excel, PowerPoint, and Word.
+ Excellent verbal and written communication skills.
+ High regard for superior quality of service.
+ Ability to prioritize and manage multiple responsibilities.
+ Experience handling tasks where attention to detail is critical to success.
+ Bilingual Spanish would be an asset.
**What is expected of you and others at this level:**
+ Demonstrates strong leadership and collaboration skills with a proven ability to develop and execute effective quality assurance programs.
+ Works independently within established procedures; may receive general guidance on new assignments.
+ May provide general guidance or technical assistance to less experienced team members.
+ Excellent attention to detail and problem-solving skills.
+ Strong communication and interpersonal skills.
+ Ability to analyze data and generate reports.
+ Ability to drive process improvements and implement quality assurance procedures.
**TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CT, mandatory attendance is required.
This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CT.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
+ Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable. Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CT, mandatory attendance is required.
This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CT.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. **Dial-up, satellite, WIFI, Cellular connections are NOT acceptable** . Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**Anticipated hourly range:** $21.50 per hour - $30.70 per hour
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 12/22/2025 *if interested in opportunity, please submit application as soon as possible. The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
**Together, we can get life-changing therapies to patients who need them-faster.**
**What Performance Monitoring contributes to Cardinal Health:**
Performance Monitoring is responsible for establishing, maintaining, and enhancing customer business through contract administration, customer orders, and problem resolution. Performance Monitoring is responsible for monitoring, analyzing, and reviewing customer contact quality.
**Responsibilities:**
+ Evaluate calls and cases to assess performance based on a standard set of criteria, providing constructive feedback and recognition to employees to ensure high performance and continuous improvement.
+ Accurately score transactions to gauge employee's quality performance based on organizational and departmental policies and requirements.
+ Monitor and evaluate team performance, whether voice or non-voice, of assigned entity and team, ensuring adherence to company quality standards, and compliance with industry regulations.
+ Track and report any trends from the customer experience that can be improved or celebrated.
+ Analyze and provide weekly & monthly trend analysis to leadership.
+ Provide support to leadership by participating in and hosting internal/external client calibration sessions.
+ Engage in and lead projects to promote quality enhancements and/or broaden services for the team.
+ Maintain a comprehensive understanding of quality systems and methodologies as well as knowledge of applicable regulations, standards, and operating procedures.
+ Conduct investigations/root cause analysis and formulate corrective action recommendations.
+ Show an understanding of the program requirements and be capable of conducting gap assessments based on those requirements.
+ Uphold quality standards that adhere to company, regulatory, and HIPAA policies and procedures.
+ Collaborate across various functions, interpret requirements, educate and influence others regarding those requirements.
+ Identify training needs or potential disciplinary actions which will be reported to leadership.
+ Build strong customer relationships and deliver customer-centric solutions.
+ Optimize work processes by identifying effective and efficient methods to complete tasks, with an emphasis on continuous improvement.
+ Develop strategic alliances and cooperate with stakeholders to achieve mutual goals.
+ Demonstrate resourcefulness by adeptly securing and efficiently deploying resources.
+ Analyze complex and high-quality, sometimes contradictory, information to solve problems effectively.
+ Hold oneself and others accountable for meeting commitments and objectives.
+ Exhibit situational adaptability by adjusting approach and demeanor in real time to meet the changing demands of various situations.
+ Create and implement diverse communication strategies that clearly address the specific requirements of various target audiences.
**Qualifications:**
+ HS Diploma, GED or technical certification in related field or equivalent experience, preferred. Diploma or degree in relevant field desirable.
+ 3+ years' call quality audit experience strongly preferred.
+ 3+ years' experience in a patient support program or hub field would be an asset.
+ Adverse Event reporting and reconciliation experience strongly preferred.
+ Data collection and trend reporting experience is essential for this role.
+ Proficiency in MS Office applications required - Outlook, Excel, PowerPoint, and Word.
+ Excellent verbal and written communication skills.
+ High regard for superior quality of service.
+ Ability to prioritize and manage multiple responsibilities.
+ Experience handling tasks where attention to detail is critical to success.
+ Bilingual Spanish would be an asset.
**What is expected of you and others at this level:**
+ Demonstrates strong leadership and collaboration skills with a proven ability to develop and execute effective quality assurance programs.
+ Works independently within established procedures; may receive general guidance on new assignments.
+ May provide general guidance or technical assistance to less experienced team members.
+ Excellent attention to detail and problem-solving skills.
+ Strong communication and interpersonal skills.
+ Ability to analyze data and generate reports.
+ Ability to drive process improvements and implement quality assurance procedures.
**TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CT, mandatory attendance is required.
This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CT.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
+ Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. Dial-up, satellite, WIFI, Cellular connections are NOT acceptable. Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**TRAINING AND WORK SCHEDULES:** Your new hire training will take place 8:00am-5:00pm CT, mandatory attendance is required.
This position is full-time (40 hours/week). Employees are required to have flexibility to work any of our shift schedules during our normal business hours of Monday-Friday, 7:00am- 7:00pm CT.
**REMOTE DETAILS:** You will work remotely, full-time. It will require a dedicated, quiet, private, distraction free environment with access to high-speed internet. We will provide you with the computer, technology and equipment needed to successfully perform your job. You will be responsible for providing high-speed internet. Internet requirements include the following:
Maintain a secure, high-speed, broadband internet connection (DSL, Cable, or Fiber) at the remote location. **Dial-up, satellite, WIFI, Cellular connections are NOT acceptable** . Download speed of 15Mbps (megabyte per second)
+ Upload speed of 5Mbps (megabyte per second)
+ Ping Rate Maximum of 30ms (milliseconds)
+ Hardwired to the router
+ Surge protector with Network Line Protection for CAH issued equipment
**Anticipated hourly range:** $21.50 per hour - $30.70 per hour
**Bonus eligible:** No
**Benefits:** Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
+ Medical, dental and vision coverage
+ Paid time off plan
+ Health savings account (HSA)
+ 401k savings plan
+ Access to wages before pay day with myFlexPay
+ Flexible spending accounts (FSAs)
+ Short- and long-term disability coverage
+ Work-Life resources
+ Paid parental leave
+ Healthy lifestyle programs
**Application window anticipated to close:** 12/22/2025 *if interested in opportunity, please submit application as soon as possible. The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (
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5
Scientist II, Quality Control
53786 Madison, Wisconsin
Danaher Corporation
Posted 1 day ago
Job Viewed
Job Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Aldevron, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life-impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential-one discovery at a time.
Learn about the Danaher Business System ( which makes everything possible.
The Scientist II, Quality Control is responsible for performing a broad range of QC assays to support manufacturing, stability, and method validation. The Scientist II is a Subject Matter Expert in one or more analytical technical areas.
This position reports to the Quality Control Supervisor and is part of the Quality Control Group located in Madison, Wisconsin and will be an on-site role.
In this role, you will have the opportunity to:
+ Independently perform complex QC assays for biological macromolecules (Concentration, Purity, Activity, Residual, Compendial) according to established standard operating procedures under minimal direction from the QC Supervisor
+ Represent Aldevron in internal and external client meetings as a Subject Matter Expert in one or more analytical technical areas
+ Lead investigations for Out of Specification / Out of Trend results using hypothesis tests and root cause analysis techniques; applies sustainable corrective actions
+ Train and mentor Quality Control Scientists and Analysts
+ Write and revise Standard Operating Procedures, Forms, Protocols, and Reports
The essential requirements of the job include:
+ Bachelor's degree in Scientific field + 5 years of experience working in a related laboratory environment OR Master's +2 years OR Ph.D. + 1 year
+ Knowledge of Quality Management Systems (ISO 13485 or cGMP) and Good Documentation Practices
+ Experience in writing complex technical SOPs for clarity and ease of use
It would be a plus if you also possess previous experience in:
+ Analytical Method Optimization and Transfer
+ Electronic Laboratory Information Management Systems (LIMS)
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
#LI-GC1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Aldevron, one of Danaher's ( 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life-impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential-one discovery at a time.
Learn about the Danaher Business System ( which makes everything possible.
The Scientist II, Quality Control is responsible for performing a broad range of QC assays to support manufacturing, stability, and method validation. The Scientist II is a Subject Matter Expert in one or more analytical technical areas.
This position reports to the Quality Control Supervisor and is part of the Quality Control Group located in Madison, Wisconsin and will be an on-site role.
In this role, you will have the opportunity to:
+ Independently perform complex QC assays for biological macromolecules (Concentration, Purity, Activity, Residual, Compendial) according to established standard operating procedures under minimal direction from the QC Supervisor
+ Represent Aldevron in internal and external client meetings as a Subject Matter Expert in one or more analytical technical areas
+ Lead investigations for Out of Specification / Out of Trend results using hypothesis tests and root cause analysis techniques; applies sustainable corrective actions
+ Train and mentor Quality Control Scientists and Analysts
+ Write and revise Standard Operating Procedures, Forms, Protocols, and Reports
The essential requirements of the job include:
+ Bachelor's degree in Scientific field + 5 years of experience working in a related laboratory environment OR Master's +2 years OR Ph.D. + 1 year
+ Knowledge of Quality Management Systems (ISO 13485 or cGMP) and Good Documentation Practices
+ Experience in writing complex technical SOPs for clarity and ease of use
It would be a plus if you also possess previous experience in:
+ Analytical Method Optimization and Transfer
+ Electronic Laboratory Information Management Systems (LIMS)
Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info ( .
#LI-GC1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .
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6
Senior Quality Control Engineer
53701 Madison, Wisconsin
$105000 Annually
WhatJobs Direct
Posted today
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Senior Quality Control Engineer to join their advanced manufacturing facility in **Madison, Wisconsin, US**. This role is essential in ensuring the highest standards of product quality and process integrity throughout the manufacturing lifecycle. The ideal candidate will possess a strong background in quality management systems, statistical process control, and root cause analysis, coupled with a proactive approach to identifying and mitigating potential defects.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain comprehensive quality control plans and procedures.
- Oversee and manage all quality assurance activities on the production floor.
- Conduct regular inspections and audits of raw materials, in-process components, and finished goods.
- Utilize statistical process control (SPC) techniques to monitor and improve manufacturing processes.
- Lead root cause analysis investigations for non-conformances and implement corrective and preventive actions (CAPA).
- Collaborate with engineering, production, and supply chain teams to address quality issues promptly.
- Develop and manage quality metrics and reporting systems, providing insights to management.
- Ensure compliance with industry standards, regulatory requirements, and customer specifications.
- Train and mentor quality technicians and other production personnel on quality procedures and best practices.
- Manage calibration and maintenance programs for quality testing equipment.
- Participate in the qualification and validation of new equipment and processes.
- Drive continuous improvement initiatives to enhance product quality and reduce waste.
- Review and approve production documentation, including work instructions and inspection records.
- Bachelor's degree in Engineering (Mechanical, Electrical, Industrial) or a related technical field.
- Minimum of 7 years of experience in quality control or quality assurance within a manufacturing environment.
- In-depth knowledge of quality management systems (e.g., ISO 9001, AS9100, IATF 16949).
- Proficiency in statistical analysis tools and software (e.g., Minitab, JMP).
- Experience with Six Sigma methodologies and Green/Black Belt certification is highly desirable.
- Strong understanding of various manufacturing processes and quality inspection techniques.
- Excellent analytical, problem-solving, and decision-making abilities.
- Superior communication, interpersonal, and leadership skills.
- Ability to read and interpret blueprints, technical drawings, and specifications.
- Experience with metrology and calibration principles.
- Familiarity with Lean Manufacturing principles.
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7
Advanced Quality Control Technician
53703 Madison, Wisconsin
$28 Hourly
WhatJobs Direct
Posted 1 day ago
Job Viewed
Job Description
Our client is seeking a highly skilled and meticulous Advanced Quality Control Technician to join their dynamic manufacturing facility in Madison, Wisconsin, US . This is a critical role responsible for ensuring the highest standards of product quality throughout the production process. The ideal candidate will possess a strong understanding of manufacturing processes, quality control methodologies, and statistical analysis. You will be instrumental in identifying, analyzing, and resolving quality issues, contributing directly to the efficiency and reputation of our production lines.
Key Responsibilities:
Key Responsibilities:
- Conduct thorough inspections and tests on raw materials, in-process components, and finished goods to verify compliance with specifications and quality standards.
- Operate and maintain a variety of precision measurement and testing equipment.
- Analyze test results, identify trends, and report deviations to engineering and production teams.
- Develop and implement corrective actions to address quality issues and prevent recurrence.
- Participate in root cause analysis investigations for non-conforming products.
- Contribute to the continuous improvement of quality control procedures and documentation.
- Maintain accurate and comprehensive records of all quality control activities.
- Collaborate with production staff to ensure adherence to quality protocols and standards.
- Stay updated on industry best practices and emerging quality control technologies.
- Assist in the training of new quality control personnel.
- Ensure a safe and organized work environment, adhering to all safety regulations.
- Associate's or Bachelor's degree in a related field (e.g., Manufacturing Technology, Engineering) or equivalent practical experience.
- Proven experience (3+ years) in a quality control role within a manufacturing environment.
- Proficiency in using various quality control instruments and testing equipment.
- Solid understanding of ISO 9001 or similar quality management systems.
- Familiarity with statistical process control (SPC) techniques.
- Strong analytical and problem-solving skills with a keen eye for detail.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team.
- Proficiency in Microsoft Office Suite, particularly Excel for data analysis.
- Ability to read and interpret technical drawings and specifications.
- Must be able to work effectively in a hybrid model, balancing on-site responsibilities with potential remote collaboration.
- Physical ability to stand for extended periods, lift moderate weights, and perform manual tasks as required.
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8
Quality Control Manager, Manufacturing
53701 Madison, Wisconsin
$80000 Annually
WhatJobs Direct
Posted 1 day ago
Job Viewed
Job Description
Our client is seeking an experienced and meticulous Quality Control Manager to lead their quality assurance initiatives within their manufacturing operations in **Madison, Wisconsin, US**. This crucial role will be responsible for establishing and maintaining robust quality control systems to ensure products consistently meet high standards and regulatory requirements. You will oversee inspection processes, implement quality improvement programs, manage a team of quality technicians, and collaborate with production and engineering teams to identify and resolve quality issues. The ideal candidate will possess a strong understanding of manufacturing quality principles, excellent analytical skills, and proven leadership capabilities.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and manage the company's quality control system in accordance with industry standards and customer requirements.
- Oversee all quality inspection and testing activities, ensuring product conformity at various stages of the manufacturing process.
- Manage and train a team of quality control inspectors and technicians, providing guidance and support.
- Establish and monitor key quality metrics, analyzing trends and implementing corrective and preventive actions (CAPA).
- Collaborate closely with production and engineering teams to address quality concerns and implement process improvements.
- Conduct regular internal audits of manufacturing processes and quality systems.
- Ensure compliance with relevant quality standards (e.g., ISO 9001) and regulatory requirements.
- Manage the disposition of non-conforming materials and products.
- Develop and maintain quality documentation, including inspection procedures and quality reports.
- Lead continuous improvement initiatives aimed at enhancing product quality and reducing defects.
- Act as the primary point of contact for quality-related customer inquiries and audits.
- Stay abreast of evolving quality control technologies and best practices.
Qualifications:
- Bachelor's degree in Engineering, Quality Management, or a related field.
- Minimum of 5 years of experience in quality control or quality assurance within a manufacturing environment.
- Proven experience in developing and implementing quality management systems.
- Strong understanding of manufacturing processes and quality control methodologies (e.g., Six Sigma, Lean, SPC).
- Experience with quality inspection tools and techniques.
- Excellent leadership, communication, and problem-solving skills.
- Proficiency in quality management software and data analysis tools.
- Ability to interpret technical drawings and specifications.
- Experience with regulatory compliance and audits is a plus.
- Strong attention to detail and a commitment to upholding quality standards.
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