Associate III, Quality Assurance
Biogen
August 20, 2026
Remote friendly (Triangle, NC)
United States
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 timely quality direction on the manufacturing floor. You will partner across Quality, Manufacturing, and PO&T to resolve quality and compliance concerns, support inspection readiness, and advance NPI technology transfers and restart programs.
What You’ll Do
- Review and approve batch and cell bank disposition documentation for cGMP compliance and product acceptability
- Review 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 and site-procedure requirements
- Support resolution of technical and compliance issues (low to moderate complexity)
- Support 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/approval of related documentation (with management oversight)
- Assist with Quality Management Systems and GxP training implementation
- Communicate quality issues and decisions across functions
Required Skills
- Bachelor’s degree (preferred life science)
- 2+ years in quality GMP biopharma/pharma
- Working knowledge of GxP/cGMP and FDA/EMA expectations
- Understanding of quality systems 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 and disposition documentation
- Understanding of biopharma/pharma manufacturing processes
Benefits/Compensation (if applicable)
- Base pay range: $69,000.00–$90,000.00
- Medical, dental, vision, life; fitness/wellness; disability; paid vacation/shutdown; paid holidays; sick time; maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups
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 timely quality direction on the manufacturing floor. You will partner across Quality, Manufacturing, and PO&T to resolve quality and compliance concerns, support inspection readiness, and advance NPI technology transfers and restart programs.
What You’ll Do
- Review and approve batch and cell bank disposition documentation for cGMP compliance and product acceptability
- Review 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 and site-procedure requirements
- Support resolution of technical and compliance issues (low to moderate complexity)
- Support 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/approval of related documentation (with management oversight)
- Assist with Quality Management Systems and GxP training implementation
- Communicate quality issues and decisions across functions
Required Skills
- Bachelor’s degree (preferred life science)
- 2+ years in quality GMP biopharma/pharma
- Working knowledge of GxP/cGMP and FDA/EMA expectations
- Understanding of quality systems 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 and disposition documentation
- Understanding of biopharma/pharma manufacturing processes
Benefits/Compensation (if applicable)
- Base pay range: $69,000.00–$90,000.00
- Medical, dental, vision, life; fitness/wellness; disability; paid vacation/shutdown; paid holidays; sick time; maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups