76 Qa Lab Technician jobs in Milwaukee
Quality Assurance Specialist
54235 Whitefish Bay, Wisconsin
Actalent
Posted 1 day ago
Job Viewed
Job Description
Quality Assurance Specialist
Job Description
Join our team as a Quality Assurance Specialist where you will play a crucial role in ensuring the highest quality standards for our products and processes. You will conduct inspections using hand measurement tools and Optical CMM, maintain SOPs and quality records, and drive quality improvements across the board.
Responsibilities
+ Conduct product and process inspections using hand measurement tools such as micrometers and calipers, and Optical CMM.
+ Maintain and control SOPs, quality records, and work instructions.
+ Identify and lead initiatives to improve product and process quality.
+ Educate employees on quality processes and best practices.
+ Track and report quality KPIs to stakeholders.
+ Collaborate with production, engineering, and R&D teams.
+ Utilize customer feedback to identify issues and drive improvements.
+ Identify, document, and address quality deviations through nonconformance management.
+ Perform internal audits and inspections of products and processes.
Essential Skills
+ Proficiency in quality assurance and quality tools such as Root Cause Analysis (5 Whys, Fishbone), and FMEA.
+ Strong data analysis and visualization skills using Excel, Tableau, and Power BI.
+ 1-2 years of experience in manufacturing and quality.
+ Experience with QMS, ERP (SAP, Oracle), and document management systems.
+ Understanding of regulatory standards such as ISO, FDA, and GMP.
+ Excellent written and verbal communication skills.
Additional Skills & Qualifications
+ Good documentation skills.
+ Basic knowledge of micrometers and calipers.
+ Ability to work in both office and manufacturing settings.
Work Environment
The role involves primarily working on a computer documenting data, with some work on the manufacturing floor. There is a strong emphasis on computer-based tasks, providing a balance between office and floor environments. The project is extensive, offering significant growth opportunities.
Pay and Benefits
The pay range for this position is $23.00 - $26.00/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
Job Description
Join our team as a Quality Assurance Specialist where you will play a crucial role in ensuring the highest quality standards for our products and processes. You will conduct inspections using hand measurement tools and Optical CMM, maintain SOPs and quality records, and drive quality improvements across the board.
Responsibilities
+ Conduct product and process inspections using hand measurement tools such as micrometers and calipers, and Optical CMM.
+ Maintain and control SOPs, quality records, and work instructions.
+ Identify and lead initiatives to improve product and process quality.
+ Educate employees on quality processes and best practices.
+ Track and report quality KPIs to stakeholders.
+ Collaborate with production, engineering, and R&D teams.
+ Utilize customer feedback to identify issues and drive improvements.
+ Identify, document, and address quality deviations through nonconformance management.
+ Perform internal audits and inspections of products and processes.
Essential Skills
+ Proficiency in quality assurance and quality tools such as Root Cause Analysis (5 Whys, Fishbone), and FMEA.
+ Strong data analysis and visualization skills using Excel, Tableau, and Power BI.
+ 1-2 years of experience in manufacturing and quality.
+ Experience with QMS, ERP (SAP, Oracle), and document management systems.
+ Understanding of regulatory standards such as ISO, FDA, and GMP.
+ Excellent written and verbal communication skills.
Additional Skills & Qualifications
+ Good documentation skills.
+ Basic knowledge of micrometers and calipers.
+ Ability to work in both office and manufacturing settings.
Work Environment
The role involves primarily working on a computer documenting data, with some work on the manufacturing floor. There is a strong emphasis on computer-based tasks, providing a balance between office and floor environments. The project is extensive, offering significant growth opportunities.
Pay and Benefits
The pay range for this position is $23.00 - $26.00/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
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0
Quality Assurance Manager
53208 Milwaukee, Wisconsin
U.S. Bank
Posted 5 days ago
Job Viewed
Job Description
At U.S.
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1
Quality Assurance Specialist
53208 Milwaukee, Wisconsin
ManpowerGroup
Posted 10 days ago
Job Viewed
Job Description
Our Fortune 500 client in Remote is looking for hardworking, motivated talent to join their innovative team. Are you an Quality Assurance Specialist with a passion for collaborating with multiple teams and an interest in working onsite? Don't wait. apply today!
Position Title: Quality Assurance Specialist
Location: 100% Remote
Duration: 12+ months with high possibilities of extension
Pay Rate: $25/hr on W2
NEED HVAC Experience
Heavy Excel REQUIRED!
Description:
Quality Assurance Specialist - REMOTE:
Quality Assurance Specialist responsible for monitoring, inspecting, and proposing measures to correct information submitted to establish and bill for chiller connection to digital services.
Proficient with MS Office (Word, Excel, Outlook, PowerPoint, OneNote, Access)
Are you interested ? Please click apply button!
If you are not available or if this is not the right role at the moment, please share the job description with your friends and let us know if any of them show interest.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells**
_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _-_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote,
Position Title: Quality Assurance Specialist
Location: 100% Remote
Duration: 12+ months with high possibilities of extension
Pay Rate: $25/hr on W2
NEED HVAC Experience
Heavy Excel REQUIRED!
Description:
Quality Assurance Specialist - REMOTE:
Quality Assurance Specialist responsible for monitoring, inspecting, and proposing measures to correct information submitted to establish and bill for chiller connection to digital services.
Proficient with MS Office (Word, Excel, Outlook, PowerPoint, OneNote, Access)
Are you interested ? Please click apply button!
If you are not available or if this is not the right role at the moment, please share the job description with your friends and let us know if any of them show interest.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells**
_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _-_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote,
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2
Senior Quality Assurance Engineer
53201 Milwaukee, Wisconsin
$105000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a leading innovator in the manufacturing sector, is seeking a highly motivated Senior Quality Assurance Engineer to join their team in Milwaukee, Wisconsin, US . This role is critical in ensuring the highest standards of product quality and process efficiency across all manufacturing operations. The ideal candidate will possess extensive experience in quality control methodologies, statistical process control (SPC), and root cause analysis. You will be responsible for developing and implementing robust quality assurance programs, conducting audits, and driving continuous improvement initiatives to minimize defects and enhance customer satisfaction.
Key responsibilities include establishing quality standards, designing and executing test plans, and analyzing product performance data. You will work closely with production, engineering, and R&D teams to identify and resolve quality issues proactively. Proficiency in using quality management software and analytical tools is essential. Experience with ISO 9001 standards or other relevant quality certifications is highly desirable. The ability to lead and mentor junior QA personnel, manage cross-functional quality projects, and communicate effectively with all levels of the organization is paramount.
A Bachelor's degree in Engineering (Mechanical, Electrical, or Industrial) or a related technical field, combined with a minimum of 7 years of experience in quality assurance within a manufacturing environment, is required. Strong analytical and problem-solving skills, meticulous attention to detail, and a commitment to excellence are essential attributes for success in this role. This is an excellent opportunity to contribute to a company renowned for its commitment to quality and innovation.
Responsibilities:
Key responsibilities include establishing quality standards, designing and executing test plans, and analyzing product performance data. You will work closely with production, engineering, and R&D teams to identify and resolve quality issues proactively. Proficiency in using quality management software and analytical tools is essential. Experience with ISO 9001 standards or other relevant quality certifications is highly desirable. The ability to lead and mentor junior QA personnel, manage cross-functional quality projects, and communicate effectively with all levels of the organization is paramount.
A Bachelor's degree in Engineering (Mechanical, Electrical, or Industrial) or a related technical field, combined with a minimum of 7 years of experience in quality assurance within a manufacturing environment, is required. Strong analytical and problem-solving skills, meticulous attention to detail, and a commitment to excellence are essential attributes for success in this role. This is an excellent opportunity to contribute to a company renowned for its commitment to quality and innovation.
Responsibilities:
- Develop and implement quality assurance plans and procedures.
- Conduct root cause analysis for non-conformances and implement corrective actions.
- Monitor and analyze production processes using SPC and other quality tools.
- Perform product testing and validation.
- Lead quality audits and ensure compliance with standards.
- Collaborate with cross-functional teams to improve product quality and reliability.
- Bachelor's degree in Engineering or a related technical field.
- Minimum 7 years of experience in Quality Assurance in manufacturing.
- Expertise in SPC, FMEA, and root cause analysis techniques.
- Familiarity with ISO 9001 standards.
- Strong analytical and problem-solving skills.
- Excellent communication and leadership abilities.
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3
Automotive Quality Assurance Engineer
53201 Milwaukee, Wisconsin
$88000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client is looking for a meticulous and experienced Automotive Quality Assurance Engineer to be based in Milwaukee, Wisconsin, US . This role is integral to ensuring the highest standards of quality in our automotive components and systems. You will be responsible for developing and implementing robust quality control processes, conducting rigorous testing and inspection of parts and finished products, and analyzing data to identify root causes of defects. This position requires a deep understanding of automotive manufacturing processes, quality management systems (e.g., ISO 9001, IATF 16949), and statistical process control (SPC) techniques. You will work closely with design, manufacturing, and supplier teams to proactively address quality issues and implement corrective actions. Responsibilities include creating detailed test plans and procedures, performing failure mode and effects analysis (FMEA), and managing non-conforming materials. You will also be involved in supplier quality audits and development, ensuring they meet our stringent quality requirements. The ideal candidate will have a Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related technical field, coupled with at least 4 years of experience in quality assurance within the automotive industry. Strong knowledge of GD&T (Geometric Dimensioning and Tolerancing), APQP (Advanced Product Quality Planning), and PPAP (Production Part Approval Process) is essential. Excellent problem-solving skills, a keen eye for detail, and proficiency in quality tools and software are also required. The ability to interpret technical drawings and specifications is paramount. You will be a key contributor to continuous improvement initiatives and will play a vital role in upholding our reputation for excellence in the automotive sector. This role requires excellent interpersonal and communication skills to collaborate effectively with cross-functional teams and external partners.
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4
Automotive Quality Assurance Lead
53201 Milwaukee, Wisconsin
$95000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client is seeking a highly experienced Automotive Quality Assurance Lead to oversee quality control processes for their automotive manufacturing operations in Milwaukee, Wisconsin, US . This pivotal role involves leading a team of QA professionals, implementing rigorous testing procedures, and ensuring that all products meet stringent industry standards and customer expectations. The Lead will be responsible for developing and executing comprehensive quality assurance plans, including identifying critical control points, conducting root cause analysis for defects, and implementing corrective and preventive actions (CAPA). You will collaborate closely with production, engineering, and supply chain teams to embed quality into every stage of the product lifecycle, from design and development to final assembly and shipping. Key responsibilities include managing the calibration and maintenance of testing equipment, ensuring compliance with ISO/TS 16949 (or IATF 16949) standards, and preparing detailed quality reports for senior management. The ideal candidate will have a strong understanding of automotive manufacturing processes, statistical process control (SPC), and various quality tools such as FMEA, APQP, and Six Sigma. This role requires exceptional leadership, communication, and problem-solving abilities, as well as a meticulous attention to detail. You will be instrumental in driving continuous improvement initiatives to enhance product quality and reduce warranty claims. This position demands a hands-on approach and the ability to effectively motivate and guide a team towards achieving collective quality goals. The Lead will also be involved in supplier quality management, assessing vendor performance and ensuring incoming materials meet specified requirements.
Qualifications:
Qualifications:
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical field.
- 7+ years of experience in quality assurance within the automotive industry.
- Proven experience in a leadership or supervisory role.
- In-depth knowledge of IATF 16949 quality management system and its requirements.
- Proficiency in quality tools such as SPC, FMEA, APQP, PPAP, and MSA.
- Experience with Lean Manufacturing and Six Sigma methodologies.
- Strong understanding of automotive manufacturing processes and systems.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional communication, interpersonal, and team leadership abilities.
- Familiarity with metrology and calibration principles.
- ASQ Certified Quality Engineer (CQE) or similar certification is preferred.
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5
Quality Control / Quality Assurance Supervisor
53208 Milwaukee, Wisconsin
Reyes Holdings
Posted 11 days ago
Job Viewed
Job Description
Join the leading beverage provider, Reyes Coca-Cola Bottling!
+ Shift: Full Time, 2nd Shift, 1:30pm start, some weekends
+ Benefits: Medical, Dental, Vision, 401K Match, PTO, Education Reimbursement
+ Hiring Bonus: $3,000
If you enjoy our products, you'll really enjoy being a part of our team!
Position Responsibilities:
+ The QA/QC Supervisor maintains corporate and franchise partner standards as well as environmental health and safety standards establishing operational procedures in collaboration with quality assurance manager
+ This role ensures that all work assessments and activities are in accordance with policies of the company, focusing on removing costs, continuous improvement, and removing inefficiencies
+ You will direct quality assurance employees in a Manufacturing facility ensuring that all QA equipment is in excellent operating order
+ Other duties as assigned
Required Education and Experience:
+ Associate's Degree with 4 plus years of related experience and 0 to 1 plus years of supervisory experience or High School Diploma/General Education Diploma with 6 plus years of related experience and 1 to 2 plus years of supervisory experience
Preferred Education and Experience:
+ Bachelor's degree
Benefits
At the Reyes Family of Businesses, our Total Rewards Strategy prioritizes the holistic well-being of our employees. This position offers a comprehensive benefits package that includes Medical, Dental, Vision coverage, Paid Time Off, Retirement Benefits, and complimentary Health Screenings.
Equal Opportunity Employee & Physical Demands
Reyes Holdings and its businesses are equal opportunity employers. Company policy prohibits discrimination and harassment against any applicant or employee based on race, color, religion, sex, pregnancy or pregnancy-related medical conditions, marital status, sexual orientation, gender identity or expression, age, national origin, citizenship, disability, genetic information, military or veteran status, or any other basis protected by applicable law. In addition, the Company is committed to providing reasonable accommodation to applicants and employees in accordance with applicable law. Requests for accommodation should be directed to your point of contact in the Talent Acquisition or Human Resources departments.
Background Check and Drug Screening
Offers of employment are contingent upon successful completion of a background check and drug screening.
Pay Transparency
Our compensation philosophy embraces diverse factors for fair pay decisions, valuing skills, experience, and the needs of our business. Moreover, this role may have the opportunity to participate in a discretionary incentive program, subject to program rules.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation and gender identity, national origin, disability, or protected veteran status. Drug Free Workplace.
+ Shift: Full Time, 2nd Shift, 1:30pm start, some weekends
+ Benefits: Medical, Dental, Vision, 401K Match, PTO, Education Reimbursement
+ Hiring Bonus: $3,000
If you enjoy our products, you'll really enjoy being a part of our team!
Position Responsibilities:
+ The QA/QC Supervisor maintains corporate and franchise partner standards as well as environmental health and safety standards establishing operational procedures in collaboration with quality assurance manager
+ This role ensures that all work assessments and activities are in accordance with policies of the company, focusing on removing costs, continuous improvement, and removing inefficiencies
+ You will direct quality assurance employees in a Manufacturing facility ensuring that all QA equipment is in excellent operating order
+ Other duties as assigned
Required Education and Experience:
+ Associate's Degree with 4 plus years of related experience and 0 to 1 plus years of supervisory experience or High School Diploma/General Education Diploma with 6 plus years of related experience and 1 to 2 plus years of supervisory experience
Preferred Education and Experience:
+ Bachelor's degree
Benefits
At the Reyes Family of Businesses, our Total Rewards Strategy prioritizes the holistic well-being of our employees. This position offers a comprehensive benefits package that includes Medical, Dental, Vision coverage, Paid Time Off, Retirement Benefits, and complimentary Health Screenings.
Equal Opportunity Employee & Physical Demands
Reyes Holdings and its businesses are equal opportunity employers. Company policy prohibits discrimination and harassment against any applicant or employee based on race, color, religion, sex, pregnancy or pregnancy-related medical conditions, marital status, sexual orientation, gender identity or expression, age, national origin, citizenship, disability, genetic information, military or veteran status, or any other basis protected by applicable law. In addition, the Company is committed to providing reasonable accommodation to applicants and employees in accordance with applicable law. Requests for accommodation should be directed to your point of contact in the Talent Acquisition or Human Resources departments.
Background Check and Drug Screening
Offers of employment are contingent upon successful completion of a background check and drug screening.
Pay Transparency
Our compensation philosophy embraces diverse factors for fair pay decisions, valuing skills, experience, and the needs of our business. Moreover, this role may have the opportunity to participate in a discretionary incentive program, subject to program rules.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation and gender identity, national origin, disability, or protected veteran status. Drug Free Workplace.
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6
Senior Automotive Quality Assurance Manager
53202 Milwaukee, Wisconsin
$160000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a prominent automotive manufacturer, is seeking an experienced Senior Automotive Quality Assurance Manager to lead their quality initiatives in a fully remote capacity. This role is critical for ensuring the highest standards of quality in vehicle production and component sourcing. You will be responsible for developing and implementing comprehensive quality assurance strategies, policies, and procedures across the organization. This includes overseeing quality control processes, conducting root cause analyses for defects, and driving continuous improvement initiatives. The ideal candidate will possess a Bachelor's degree in Engineering, Business Administration, or a related field, with a minimum of 10 years of experience in quality assurance or quality management, specifically within the automotive sector. Proven experience with quality management systems such as IATF 16949 is mandatory. You should have a strong understanding of quality tools and methodologies, including Six Sigma, Lean Manufacturing, FMEA, and SPC. Experience managing and developing a team of quality professionals is essential. Excellent leadership, analytical, problem-solving, and communication skills are required to effectively collaborate with internal departments and external suppliers. This is a fantastic opportunity to make a significant impact on product quality and customer satisfaction from the comfort of your home office.
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7
Senior Automotive Quality Assurance Engineer
53201 Milwaukee, Wisconsin
$95000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and experienced Senior Automotive Quality Assurance Engineer to lead quality initiatives for advanced vehicle systems in Milwaukee, Wisconsin, US . This pivotal role involves developing and implementing comprehensive quality strategies throughout the product lifecycle, from design and development to manufacturing and post-production. You will be responsible for defining quality metrics, establishing robust testing protocols, and ensuring that all automotive components and systems meet stringent industry standards and customer expectations. The Senior QA Engineer will conduct root cause analysis of quality issues, develop corrective and preventative actions (CAPA), and drive continuous improvement efforts across engineering and manufacturing teams. Collaboration is key, as you will work closely with design engineers, manufacturing engineers, suppliers, and customers to identify and resolve quality concerns proactively. This position requires a deep understanding of automotive quality management systems (e.g., IATF 16949), statistical process control (SPC), Failure Mode and Effects Analysis (FMEA), and Advanced Product Quality Planning (APQP). You will lead cross-functional teams in problem-solving activities and champion a culture of quality excellence. The ideal candidate will possess exceptional analytical skills, a keen eye for detail, and the ability to translate complex technical data into actionable insights. Experience with various automotive testing methodologies, including functional, performance, and durability testing, is essential. This is an excellent opportunity for a seasoned quality professional to make a significant impact on the development of cutting-edge automotive technologies and contribute to the company's reputation for excellence.
Responsibilities:
Responsibilities:
- Develop and implement comprehensive quality assurance plans for automotive products.
- Define and track key quality metrics and performance indicators.
- Lead root cause analysis for quality escapes and customer complaints.
- Develop and manage Corrective and Preventive Action (CAPA) plans.
- Conduct FMEA, APQP, and PPAP processes.
- Collaborate with cross-functional teams to ensure product quality throughout the development cycle.
- Oversee internal and external quality audits.
- Train and mentor junior quality engineers and technicians.
- Analyze manufacturing process data to identify areas for improvement.
- Ensure compliance with automotive industry quality standards and regulations.
- Bachelor's degree in Engineering (Mechanical, Electrical, or Automotive preferred).
- Minimum of 7 years of experience in quality assurance within the automotive industry.
- Strong knowledge of IATF 16949, APQP, PPAP, FMEA, and SPC.
- Experience with automotive systems and components.
- Proficiency in data analysis and statistical software.
- Excellent problem-solving and critical thinking skills.
- Strong leadership and communication abilities.
- Ability to work effectively in a fast-paced, team-oriented environment.
- Certified Quality Engineer (CQE) or similar certification is a plus.
- Experience with electric vehicle (EV) systems is advantageous.
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8
Senior Pharmaceutical Quality Assurance Specialist
53201 Milwaukee, Wisconsin
$92000 Annually
WhatJobs
Posted 12 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join their dedicated quality team in **Milwaukee, Wisconsin, US**. This role is essential for ensuring compliance with stringent regulatory standards throughout the pharmaceutical product lifecycle, from development to manufacturing. You will be responsible for developing, implementing, and maintaining quality systems, conducting internal audits, reviewing batch records, and investigating deviations and out-of-specification results. The ideal candidate will possess a strong understanding of cGMP, FDA regulations, and quality control principles within the pharmaceutical industry. Exceptional attention to detail, problem-solving abilities, and excellent documentation skills are critical. This position requires a commitment to maintaining the highest standards of product quality and patient safety.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain robust Quality Assurance systems and procedures.
- Conduct internal audits and inspections to ensure compliance with cGMP and regulatory requirements.
- Review and approve batch records, validation protocols, and technical reports.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and out-of-specification (OOS) results.
- Ensure all quality-related activities are documented accurately and in compliance with regulations.
- Participate in regulatory inspections and provide support to audit teams.
- Train personnel on quality standards and cGMP compliance.
- Collaborate with cross-functional teams to resolve quality issues and drive continuous improvement.
- Stay updated on regulatory changes and industry best practices.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotech industry.
- In-depth knowledge of current Good Manufacturing Practices (cGMP), FDA regulations (e.g., 21 CFR Parts 210/211), and ICH guidelines.
- Experience with quality management systems, audits, and regulatory compliance.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills, with meticulous attention to detail.
- Proficiency in electronic quality management systems (eQMS) is a plus.
- Ability to work effectively in a team environment.
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9