Sr Associate I, Quality Assurance Operations
Biogen · Research Triangle Park, NC
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
This full-time on-site role in Quality Assurance Operations oversees strategic and tactical QA functions at a Research Triangle Park facility. The Sr. Associate I reviews batch records and controlled documents for GMP compliance, investigates exceptions and quality issues, supports regulatory audits, and mentors cross-functional teams. A bachelor's degree and minimum four years of pharmaceutical or biotech quality experience are required.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-02 (originally posted 2026-08-18). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in life science or related field
- Minimum 4 years of Quality experience in GMP pharmaceutical or biotech manufacturing
- Experience reviewing and approving batch records
- Experience conducting investigations and explaining findings to quality management and regulatory bodies
- Advanced understanding of global quality systems, GxP regulations, and cGMP principles
- Excellent written, verbal, and interpersonal communication skills
- Ability to work independently and collaboratively across organizational levels
What you'll be doing
- Review Quality-related documents and batch records for GMP compliance and product disposition
- Assess criticality of exceptions and investigations; conduct thorough root cause analysis
- Review controlled GMP documents to ensure regulatory compliance and appropriate release
- Conduct area walkthroughs and work observations to identify compliance gaps and corrective actions
- Support Quality Management with day-to-day Quality Management System implementation and cGMP compliance
Privacy & handoff
This role links to Biogen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.