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Quality Assurance Team Lead
Job in
Waunakee, Dane County, Wisconsin, 53597, USA
Listed on 2026-09-25
Listing for:
Accelera
Full Time
position Listed on 2026-09-25
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
As a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.
About the RoleAs a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.
Responsibilities- Lead and mentor the on-site QA team, managing daily workflows, training, and performance evaluations to ensure operational excellence.
- Oversee the inspection and release of raw materials, intermediate products, and finished goods based on established specifications.
- Manage the lifecycle of quality documentation, including batch record reviews, deviations, investigations, change controls, and CAPAs.
- Drive the development and maintenance of robust Quality Management Systems (eQMS) to ensure alignment with FDA, ICH, and industry regulatory requirements.
- Collaborate with cross-functional teams to identify facility events, ensuring accurate documentation and timely resolution.
- Compile and present key quality metrics to leadership to support data-driven decision-making and process improvements.
- Participate in internal and external audits, proactively addressing findings to uphold the highest standards of quality compliance.
- Associate degree in a relevant field.
- 5+ years of experience in a regulated pharmaceutical or biopharmaceutical quality environment.
- Demonstrated proficiency in cGMP, batch record review, and quality management systems.
- Strong leadership capabilities with experience in workload management and team coordination.
- Bachelor’s degree in a scientific or related discipline.
- 10+ years of progressive experience in quality assurance roles.
- Advanced knowledge of Master Control or similar eQMS platforms.
- Proven track record in regulatory audit participation and CAPA management.
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