11 Manufacturing Companies jobs in Ashland City
Supervisor, Quality Control
Posted 5 days ago
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Job Description
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.
**_Job Summary_**
The Supervisor, Quality Control coordinates and supervises the analysis or inspection of products or processes for compliance with specifications and standards. This includes setting priorities for the team to ensure task completion as well as using knowledge of testing methods, products usage and applicable regulations and standards to review investigations and deviations and ensure results are consistent with acceptable testing parameters.
**_Responsibilities_**
+ Coordinates and supervises the daily activities of the quality unit or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing.
+ Oversees the quality unit and contractors who operate Analytical Equipment, Perform Analytical tests, interpret results and documents findings in accordance with SOPs and regulatory requirements.
+ Oversees and authors written procedures and other documents, including amendments.
+ Leads and facilitates the development and validation of new analytical methods as needed in alignment with ICH requirements.
+ Performs technical review of investigations, deviations and CAPAs.
+ Ensures results are consistent with acceptable test parameters and reports abnormal findings from Analytical tests to the Manager of Quality Control.
+ Trains, assesses and coaches team in laboratory procedures, techniques and career development as needed.
**_Schedule_**
+ Onsite in La Vergne, TN.
+ 40 hours per week. Typically, Monday -Thursday from 1:00 pm - 10:00 pm. In addition, candidate must be flexible to work on-call, overtime, different shifts or schedules based on business need.
**_Qualifications_**
+ Bachelor's degree in related field, or equivalent work experience, preferred
+ 4-8 years of experience in related field preferred
+ Effective written and verbal English communication skills
+ Pharmaceutical or medical device manufacturing experience a plus
**_What is expected of you and others at this level_**
+ Coordinates and supervises the daily activities of operations or business staff
+ Administers and exercises policies and procedures
+ Ensures employees operate within guidelines
+ Decisions have a direct impact to work unit operations and customers
+ Frequently interacts with subordinates, customers, and peer groups at various management levels
+ Interactions normally involve information exchange and basic problem resolution
**Anticipated salary range:** $79,700-$113,800
**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:** 12/3/2025 *if interested in opportunity, please submit application as soon as possible.
The salary 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 (
Quality Control Manager

Posted 15 days ago
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Job Description
Company Name: Baker Concrete Construction, Inc
Location:
Nashville, TN, US, 37127
**Req ID** : 6503
**Travel:** Up to 25%
**Number of Openings:** 1
Achieve more in your career with the nation's leading specialty concrete contractor. At Baker Construction, you'll be part of a team that prioritizes people, invests in their development, and offers unparalleled opportunities for professional growth. In this role, you'll be integral to building the future of our country and our company. You'll collaborate across diverse teams, have a hand in significant projects, and dive headfirst into complex challenges with the best in the industry. If you are driven to do more and have the grit to follow through, you'll have everything you need to define your career on your terms.
Make a meaningful impact with a team that values ambition and rewards initiative. Apply today and be more with Baker.
**Summary**
The **Quality Control Manager** directs all site quality control activities and manages the inspection staff. Typically certified as Inspector Level II or III in various disciplines.
**Roles and Responsibilities**
The **Quality Control Manager** will possess competency in the following areas in order to perform his/her role in a safe, productive, and effective manner. Note that the areas listed are intended to describe the general nature and level of work being performed by co-workers assigned to this role. They are not intended to be an exhaustive list of all the responsibilities, skills, efforts, or working conditions associated with this job.
+ Manages all Aspects of Quality Control
+ Oversees Staff
+ Ensures a Safe Work Environment
+ Participates in Training/Certifications
**Requirements**
+ Bachelor's Degree in an engineering, scientific, or construction-related discipline from an accredited college or university and 8 years related experience and/or training; or 10 years equivalent combination of education and experience.
+ Knowledge of construction practices (i.e., formwork, rebar, concrete placing, etc.).
+ Quality assurance-related experience preferably in the nuclear power industry (DOE/DOD facilities).
+ Quality inspector experience.
+ Demonstrated skill and knowledge with applicable quality codes and standards preferably NRC regulations.
At Baker Construction, we welcome those who are driven to make things happen. Your tenacity will be rewarded with great pay, excellent benefits, and opportunities to make your mark. This is an opportunity to own your future while working alongside co-workers who are united in our purpose to build better structures and better lives. Go further with an industry leader that puts people first, honors its word, and has the grit to achieve greatness.
Baker is an EOE Disability/Veterans Employer.
Applicants with physical and/or mental disabilities who require a reasonable accommodation for any or part of the application process may make their requests known by emailing or calling and asking for HR.
Quality Control Manager

Posted 15 days ago
Job Viewed
Job Description
Location: Clarksville, TN. On-Site
Shift: 1st Shift
ABOUT YOU:
Are you an experienced Quality Control Manager looking for a challenging and rewarding role in Manufacturing?
Our Quality Control Manager is responsible for implementing and executing quality control methods for the plant and for developing, and managing the systems needed to ensure our products meet or exceed company standards, regulatory requirements, and customer expectations.
They oversee and manage all quality control processes and monitor quality control department operations as well as quality engineering. Together, they analyze, investigate and troubleshoot product and production issues, developing corrective actions, solutions and improvements, while implementing quality standards.
Our Quality Control Manager supports and partners with continuous improvement engineers to drive process improvement and quality goals.
YOU HAVE:
+ Education: Bachelors Degree in Quality, Business, Manufacturing, Engineering, and/or related field, or equivalent experience.
+ Experience: 5+ years of experience in Quality Control, Manufacturing, Process Management/Engineering.
+ Leadership & Innovation: Demonstrated success leading a team as a Manager or Supervisor. Displays a history of game-changing strategies and transformation initiatives.
+ Systems & Tools expertise: Advanced skills in Excel and strong Word, PowerPoint and Outlook experience. ERP & QMS Software experience a plus.
+ Technical Proficiency: Strong knowledge of QC control methodologies, inspection techniques, manufacturing processes and product development.
+ Communication & Collaboration: Great interpersonal skills, strong communication and problem-solving skills. Well developed influencing, presentation and negotiating skills.
+ Analytical & Organizational Strength: Excellent analytical thinking, detail-oriented, and time management skills, with the ability to manage multiple priorities.
+ Methodologies or Lean Principles: Lean Six-Sigma, Kaizen, and/or Lean Manufacturing, Continuous Improvement training or experience.
+ Preferred skills: Certifications in CQE, CMQ/OE and/or Lean Six Sigma Certification. ERP and QMS Software experience.
YOU WILL:
+ Manage Quality Control Processes: Develop and implement Quality Control procedures and policies to ensure our products and services meet and exceed customer expectations.
+ Implement and Grow QC Systems: Lead the development of the Quality Management Systems, focusing on quality objectives and customer satisfaction.
+ Provide Performance Insights to Leadership: Conduct in-depth analysis of quality reports/data and audit findings, and deliver strategic recommendations to senior leadership.
+ Partner with Stakeholders: Serve as a consultative advisor to the Operations team on Quality Control policies, practices and objectives, as well as plans for improvement. Collaborate with operations, manufacturing engineering and their teams to ensure quality goals are met.
+ Communicate Vision and Goals: Present complex data in an engaging and visually attractive format, tailoring the message according to your audience, while supporting the business objectives.
+ Lead and Develop a Team: Manage quality control direct and indirect reports, supporting their professional development, fostering growth and accountability, and ensuring team success.
+ Maintain Vendor Relationships: Create and maintain relationships with suppliers to ensure they meet our demand, specifications, and other requirements in a timely manner.
+ Support Change & Innovation: Cultivate a mindset of flexibility and openness, embracing and leading change, new ideas, collaboration, continuous improvement and adaptability.
LOVE WHERE YOU WORK:
+ We care about your health. We offer competitive healthcare (health, dental, vision, coverage) in addition to voluntary benefits including home and car insurance, pet insurance, flexible spending account, amongst many more.
+ We invest in your future. Our 401K plan has immediate vesting, so you can start saving for retirement right away.
+ We want you to unplug when needed. We believe in taking your time off without guilt and offer accrued paid time off and company paid holidays.
+ We care about your development. We support tuition reimbursement after 6 months of service.
ABOUT US:
Jostens leads the student commemoration market and has been serving local communities for over 125 years. We work with thousands of K-12 schools, colleges and universities each year, and have the honor of partnering with beloved sports teams and esteemed organizations across the country. Our iconic products - like yearbooks, letter jackets, class jewelry and championship rings - keep meaningful traditions alive and inspire millions of people to celebrate their unique stories, milestone moments and biggest accomplishments every year. We have 13 first-class facilities across the globe, from North America to the Caribbean. Watch a short video about us here ( .
AMERICANS WITH DISABILITIES ACT (ADA):
Jostens is committed to the full inclusion of all qualified individuals. If reasonable accommodation is required to fully participate in the job application or interview process, or to perform the essential functions of the position, please reach out to our HR team at
Jostens is an Equal Opportunity Employer and complies with applicable employment laws. EOE/M/F/Vet/Disabled are encouraged to apply.
California Privacy Policy:
Senior Coordinator, Quality Control
Posted 13 days ago
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Job Description
**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 CST, mandatory attendance is required.
This position is full-time (8-hour shifts, 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- 8:00pm CST.
**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:** $21.90 per hour - $31.40 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:** 10/10/2025. 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.
+ Works independently within established procedures; may receive general guidance on new assignments
+ May provide general guidance or technical assistance to less experienced team members
_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 (
Quality Control Senior Manager

Posted 15 days ago
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Job Description
**Introduction**
Do you have the career opportunities as a Quality Control Senior Manager you want with your current employer? We have an exciting opportunity for you to join HCA Healthcare which is part of the nation's leading provider of healthcare services, HCA Healthcare.
**Benefits**
HCA Healthcare offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:
+ Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.
+ Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.
+ Free counseling services and resources for emotional, physical and financial wellbeing
+ 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
+ Employee Stock Purchase Plan with 10% off HCA Healthcare stock
+ Family support through fertility and family building benefits with Progyny and adoption assistance.
+ Referral services for child, elder and pet care, home and auto repair, event planning and more
+ Consumer discounts through Abenity and Consumer Discounts
+ Retirement readiness, rollover assistance services and preferred banking partnerships
+ Education assistance (tuition, student loan, certification support, dependent scholarships)
+ Colleague recognition program
+ Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)
+ Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.
Learn more about Employee Benefits ( Eligibility for benefits may vary by location._**
Our teams are a committed, caring group of colleagues. Do you want to work as a Quality Control Senior Manager where your passion for creating positive patient interactions is valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!
**Job Summary**
We are seeking a diligent and experienced Senior Manager, Clinical Review, Quality Control to ensure the quality and accuracy of clinical reviews. This role is pivotal in identifying and addressing payer medical policy issues, supporting the regulatory compliance team, and enhancing the overall quality of our clinical processes. The Senior Manager will analyze physician documentation, assist with quality control and oversight, and serve as a subject matter expert for educational programs. This position also involves active participation in leadership meetings and contributing to the onboarding of new physician advisors.
**Major Responsibility**
+ Perform rigorous quality control on clinical reviews, focusing on patient status, level of care, and length of stay to ensure accuracy and compliance.
+ Proactively identify and address payer medical policies that lead to inappropriate denials, advocating for fair and accurate coverage.
+ Provide crucial support to the regulatory compliance team in managing appeals and improving documentation to meet regulatory standards.
+ Serve as a subject matter expert, guiding clinical appeal and peer-to-peer processes with expertise and insight.
+ Actively participate in leadership meetings, contributing to strategic decision-making, and assist in the onboarding of new physician advisors, ensuring they are well-prepared for their roles.
+ Conduct thorough quality control on accounts that have been reviewed, specifically focusing on patient status, level of care, and resolution of length of stay disputes. This includes assessing inpatient vs. outpatient observation status and ensuring compliance with the two-midnight rule.
+ Respond promptly to requests for intervention from the centralized peer-to-peer team and others regarding denials and appeals processes, observation level of care, decisions about admission, patient transitions, and other situations as needed.
+ Analyze and monitor physician documentation to pinpoint areas needing improvement, ensuring comprehensive and accurate records.
+ Support regulatory team members by highlighting accurate clinical documentation in appeals to substantiate the medical necessity of provided services.
+ Serve as a subject matter expert, coordinating ongoing educational programs to strengthen clinical appeal and peer-to-peer processes.
+ Bring potential or actual problems in physician practices or documentation to the attention of regulatory leadership, ensuring timely and effective resolution.
+ Assist with the onboarding of new physician advisors, providing guidance and support to ensure their success.
+ Function as a key member of the executive management team, participating in leadership meetings and contributing to strategic initiatives.
**Education & Experience**
+ A minimum of 8-10 years of clinical experience is required.
+ At least 2 years of leadership experience is preferred.
+ Possess a strong clinical background, with preference given to candidates familiar with Medicare and Medicare Advantage's Two-Midnight Rule.
**Licenses, Certifications & Training:**
+ MD/DO preferred, particularly those no longer directly involved in patient care.
We are comprised of affiliated hospitals, physician practices and other sites of care across the United States and United Kingdom. The Sarah Cannon Cancer Network is transforming cancer care through integrated services and cutting-edge technologies. Our physicians can develop leading oncology programs to advance science and patient care. Providing physician-led patient care offers our doctors access to a national network of experts. This is where multidisciplinary teams come together with a goal of delivering seamlessly coordinated, quality cancer care. Through a united network of globally recognized oncology specialists, we collaborate and share best practices. We address each aspect of the cancer journey, from screening and diagnosis through treatment and survivorship, to advance our shared mission: Above all else, we are committed to the care and improvement of human life.
HCA Healthcare has been recognized as one of the World's Most Ethical Companies® by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.
"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Quality Control Senior Manager opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. **Unlock the possibilities and apply today!**
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Senior Quality Control Technician
Posted 7 days ago
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Job Description
Key responsibilities encompass the establishment of rigorous testing protocols, the calibration and maintenance of sophisticated testing equipment, and the accurate documentation of all quality-related activities. You will collaborate closely with engineering, production, and R&D teams to ensure that all products meet or exceed stringent industry standards and client specifications. A critical aspect of this role involves trend analysis of quality data, the generation of detailed reports, and the presentation of findings to management. The ideal candidate will possess a deep understanding of statistical process control (SPC) techniques and be adept at utilizing various quality management software.
Furthermore, you will play a pivotal role in continuous improvement initiatives, spearheading projects aimed at reducing waste, improving efficiency, and elevating overall product quality. This includes participating in root cause analysis for non-conforming products and developing robust preventative measures. Training and mentoring junior quality assurance staff may also be part of your remit, fostering a strong quality-conscious culture throughout the organization. Your expertise will be instrumental in ensuring our client's reputation for excellence and reliability in the competitive manufacturing sector. This is a remote-first position, demanding excellent communication and self-management skills.This position is located in Nashville, Tennessee, US and is accessible to candidates nationwide who meet the qualifications.
Quality Control Supervisor - Automotive Manufacturing
Posted 5 days ago
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Job Description
As the Quality Control Supervisor, you will lead a team of quality inspectors and technicians, providing guidance, training, and performance management. Your key responsibilities include developing and implementing quality control procedures, monitoring production lines for defects, and performing root cause analysis of quality issues. You will conduct regular audits of manufacturing processes and finished products, ensuring compliance with industry standards such as IATF 16949. Collaboration with production management, engineering, and supply chain teams to address quality concerns and implement corrective and preventative actions is crucial. You will manage the calibration and maintenance of testing equipment and oversee the documentation of all quality control activities. Reporting on quality metrics, trends, and improvement initiatives to senior management will be a regular duty. The ideal candidate will possess a Bachelor's degree in Engineering, Manufacturing Technology, or a related field, combined with at least 5 years of experience in quality control within the automotive manufacturing industry. Demonstrated leadership experience is essential. A thorough understanding of quality tools (e.g., SPC, FMEA, APQP, PPAP) and ISO/TS 16949 certification is required. Excellent problem-solving, analytical, and communication skills are necessary to effectively manage quality operations and collaborate with diverse teams. Strong decision-making abilities and a commitment to continuous improvement are vital for success in this critical role.
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Senior Pharmaceutical Quality Control Analyst
Posted 7 days ago
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Job Description
Responsibilities:
- Perform compendial and in-house analytical testing on raw materials, in-process samples, and finished products using various techniques (e.g., HPLC, GC, UV-Vis, FTIR, KF).
- Develop, validate, and transfer analytical methods in accordance with ICH guidelines and regulatory requirements.
- Investigate out-of-specification (OOS) results, identify root causes, and implement corrective and preventive actions (CAPAs).
- Write and review technical reports, method validation protocols, and standard operating procedures (SOPs).
- Operate and maintain laboratory equipment, ensuring calibration and qualification.
- Troubleshoot analytical instrumentation and experimental issues.
- Provide technical guidance and mentorship to junior analysts.
- Participate in internal and external audits, ensuring readiness for regulatory inspections.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to support product development and lifecycle management.
- Stay current with industry best practices, scientific advancements, and regulatory changes affecting pharmaceutical quality control.
- Analyze and interpret complex data sets, presenting findings clearly and concisely.
- Master's or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of hands-on experience in pharmaceutical quality control or analytical development.
- Extensive experience with various analytical techniques, particularly HPLC and GC, is essential.
- Strong understanding of cGMP, ICH guidelines, and regulatory requirements (FDA, EMA).
- Demonstrated ability to troubleshoot analytical methods and instrumentation.
- Proficiency in data analysis software and LIMS (Laboratory Information Management System).
- Excellent technical writing and documentation skills.
- Strong problem-solving and critical thinking abilities.
- Ability to work independently and as part of a collaborative team, both remotely and on-site.
- Excellent communication and presentation skills.
- Experience with method validation and transfer is highly desirable.
Senior Pharmaceutical Quality Control Analyst
Posted 7 days ago
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Job Description
The ideal candidate will possess a strong foundation in analytical chemistry and extensive experience in a pharmaceutical quality control laboratory environment. You will be proficient in operating and maintaining analytical equipment, such as HPLC, GC, UV-Vis spectrophotometers, and dissolution testers. Key responsibilities include accurately documenting test results, reviewing data for compliance with specifications, and troubleshooting any deviations or out-of-specification results. You will also be involved in method validation, stability testing, and the development and implementation of quality control procedures. We are looking for a detail-oriented individual with excellent analytical and problem-solving skills, a thorough understanding of GMP (Good Manufacturing Practices) and regulatory guidelines (e.g., FDA, ICH), and strong written and verbal communication abilities. This position requires the ability to work independently, manage multiple tasks efficiently, and collaborate effectively with other departments, including manufacturing and regulatory affairs. You will play a vital role in maintaining the integrity and marketability of our client's pharmaceutical products. Contributing to process improvements and continuous quality enhancement will be an integral part of your responsibilities.
Qualifications: Bachelor's degree in Chemistry, Pharmacy, or a related science field; minimum of 5 years of experience in pharmaceutical quality control testing; proven proficiency with analytical techniques and instrumentation (HPLC, GC, spectroscopy, etc.); strong understanding of GMP, ICH guidelines, and relevant regulatory requirements; excellent documentation, data analysis, and problem-solving skills; strong attention to detail and organizational abilities; effective communication and teamwork skills.
Senior Lead Quality Control & Sanitation Specialist
Posted 7 days ago
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Job Description
Responsibilities:
- Develop and refine comprehensive sanitation and quality control policies and procedures.
- Conduct remote audits and inspections of facilities and processes using digital tools and documentation.
- Train and certify remote staff on proper cleaning techniques, hygiene standards, and safety protocols.
- Analyze data to identify trends, risks, and areas for improvement in sanitation and quality assurance.
- Investigate and resolve sanitation-related incidents or deviations from standards.
- Ensure compliance with all relevant local, state, and federal regulations (e.g., OSHA, FDA, EPA guidelines as applicable).
- Manage and update documentation related to sanitation, quality control, and training programs.
- Collaborate with cross-functional teams to integrate sanitation best practices into all operational areas.
- Serve as the primary point of contact for remote sanitation-related inquiries and issues.
- Stay current with advancements in cleaning technologies, sanitization methods, and regulatory changes.
- Develop and maintain key performance indicators (KPIs) for sanitation and quality control effectiveness.
- Prepare detailed reports for senior management on the status of sanitation and quality programs.
Qualifications:
- Bachelor's degree in a relevant field such as Environmental Health, Public Health, Food Science, or a related discipline.
- Minimum of 7 years of progressive experience in quality control, sanitation management, or a similar role, preferably within a multi-site or dispersed operational environment.
- Demonstrated expertise in developing and implementing sanitation programs and quality management systems.
- Strong understanding of microbiology, chemical safety, and infection control principles.
- Excellent analytical, problem-solving, and decision-making skills.
- Proficiency in utilizing digital platforms for data analysis, reporting, and virtual training.
- Exceptional communication and presentation skills, with the ability to convey complex information clearly to diverse audiences.
- Experience with regulatory compliance and auditing procedures is essential.
- Ability to work independently, manage multiple priorities, and maintain strict confidentiality.
- Must possess a reliable internet connection and a suitable remote work environment.
- While this role is fully remote, occasional travel to operational sites within the Nashville, Tennessee, US region may be required (less than 10% of the time).