Associate III, Quality Assurance
Biogen
August 29, 2026
On-site
Triangle, NC
Operations
About This Role
As a QA Associate III, you will support compliant manufacturing operations by applying cGMP requirements, Biogen Quality Systems, and internal procedures. You will review and approve documentation for batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide quality direction on the manufacturing floor. You will partner across Quality, Manufacturing, and PO&T to resolve quality/compliance concerns, support inspection readiness, and advance NPI technology transfers and restart programs. You will also provide technical writing and investigation support, including root cause and impact assessments.
What You’ll Do
- Review and approve batch and cell bank disposition documentation (cGMP compliance, product acceptability)
- Review executed BPRs, PRCDs/WIs, formulas/recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs, and PARs
- Perform manufacturing-floor record review, observations, WORCs, and inspection-readiness walkthroughs
- Provide quality oversight and technical consultation on regulatory/site-procedure requirements
- Support resolution of low-to-moderate complexity technical/compliance issues
- Support QA Lead for NPI technology transfers and restart programs
- Provide investigation support, root cause analysis, and impact assessment
- Support CAPA closure and associated documentation review/approval (with management oversight)
- Assist with Quality Management Systems implementation and GxP training
- Communicate quality issues and decisions across functions
Required Skills
- Bachelor’s degree (preferred in life sciences)
- 2+ years in a quality GMP biopharma/pharma environment
- Working knowledge of GxP regulations, cGMP, and FDA/EMA expectations
- Understanding of quality systems, quality concepts, and manufacturing processes
- Strong organization, prioritization, and multi-tasking
- Excellent written, verbal, and interpersonal communication
Preferred Skills
- Investigation/root cause analysis, impact assessment, and technical writing (minor investigations/CAPA/GCC)
- Experience reviewing controlled manufacturing/disposition documentation
- Understanding of biopharma/pharma manufacturing processes
Benefits (highlights)
- Medical, Dental, Vision, Life insurance; Fitness & Wellness (fitness reimbursement)
- Short- and Long-Term Disability; Paid vacation + end-of-year shutdown; Paid holidays
- 401(k) with company match; Tuition reimbursement up to $10,000/year; Employee stock purchase plan
Compensation Range
- Base compensation: $69,000.00–$90,000.00
As a QA Associate III, you will support compliant manufacturing operations by applying cGMP requirements, Biogen Quality Systems, and internal procedures. You will review and approve documentation for batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide quality direction on the manufacturing floor. You will partner across Quality, Manufacturing, and PO&T to resolve quality/compliance concerns, support inspection readiness, and advance NPI technology transfers and restart programs. You will also provide technical writing and investigation support, including root cause and impact assessments.
What You’ll Do
- Review and approve batch and cell bank disposition documentation (cGMP compliance, product acceptability)
- Review executed BPRs, PRCDs/WIs, formulas/recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs, and PARs
- Perform manufacturing-floor record review, observations, WORCs, and inspection-readiness walkthroughs
- Provide quality oversight and technical consultation on regulatory/site-procedure requirements
- Support resolution of low-to-moderate complexity technical/compliance issues
- Support QA Lead for NPI technology transfers and restart programs
- Provide investigation support, root cause analysis, and impact assessment
- Support CAPA closure and associated documentation review/approval (with management oversight)
- Assist with Quality Management Systems implementation and GxP training
- Communicate quality issues and decisions across functions
Required Skills
- Bachelor’s degree (preferred in life sciences)
- 2+ years in a quality GMP biopharma/pharma environment
- Working knowledge of GxP regulations, cGMP, and FDA/EMA expectations
- Understanding of quality systems, quality concepts, and manufacturing processes
- Strong organization, prioritization, and multi-tasking
- Excellent written, verbal, and interpersonal communication
Preferred Skills
- Investigation/root cause analysis, impact assessment, and technical writing (minor investigations/CAPA/GCC)
- Experience reviewing controlled manufacturing/disposition documentation
- Understanding of biopharma/pharma manufacturing processes
Benefits (highlights)
- Medical, Dental, Vision, Life insurance; Fitness & Wellness (fitness reimbursement)
- Short- and Long-Term Disability; Paid vacation + end-of-year shutdown; Paid holidays
- 401(k) with company match; Tuition reimbursement up to $10,000/year; Employee stock purchase plan
Compensation Range
- Base compensation: $69,000.00–$90,000.00