QA Lead Specialist
On-site · Madison, Wisconsin, United States
Job Summary
QA Lead Specialist responsible for leading deviation and CAPA activities, overseeing review and release of final products, and mentoring Quality Assurance staff. The role focuses on driving root-cause analysis and continuous improvement, authoring and maintaining SOPs, and providing front-room support during audits (ISO 13485, internal, and client). Requires leading QA staff, coordinating metrics, and ensuring quality systems across the quality function within Aldevron’s on-site Madison, WI facility. Bachelor’s degree in Biology/Biochemistry or related field and 6+ years in ISO 13485/GxP environments are essential; MasterControl eQMS and Dynamics 365 ERP experience are a plus. The position emphasizes leadership, compliance, and collaboration to accelerate science and deliver high-quality products in a CDMO setting.
Required Qualifications
- Bachelor of Science in Biology, Biochemistry, or related field
- 6 years experience in an ISO 13485 and/or GxP environment
- 3 years experience with root cause analysis and/or technical writing
Desired Qualifications
- Experience leading Quality Assurance teams
- Expertise in ISO 13485 and GxP environments
- Strong root cause analysis and technical writing skills
- Experience with CAPA management
- Auditing experience (internal, ISO, client)
- SOP development and maintenance
- Experience with Life Sciences / biotechnology / CDMO industry
- Bachelor of Science in Biology, Biochemistry, or related field
- Lean / Continuous Improvement background is a plus
- MasterControl eQMS and Dynamics 365 ERP experience is a plus
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