Biogen
Associate III, Quality Assurance
Research Triangle Park, NC, USA · Mid
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About the role
- This individual contributor role requires sound judgment, mature situational leadership and the ability to work independently while collaborating across functions and organizational levels.
Responsibilities
- Perform manufacturing-floor record review, observations, WORCs and inspection-readiness walkthroughs
- Support resolution of technical and compliance issues or gaps of low to moderate complexity
- Support the QA Lead for NPI technology transfers and restart programs
- Provide technical writing, investigation support, root cause analysis and impact assessment
- Support CAPA closure and review or approval of associated documentation with management oversight
Requirements
- You are a detail-oriented quality professional who applies sound judgment, regulatory knowledge and a practical understanding of manufacturing to protect product quality.
- 2+ years of related experience working in a quality GMP biopharma or pharma environment
- Working knowledge of GxP regulations, cGMP requirements and relevant FDA/EMA expectations
- Experience reviewing controlled manufacturing and disposition documentation
Nice to have
- Bachelor's Degree required, preferred in a life science discipline
- Preferred Skills
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.