Associate III, Quality Assurance (On The Floor, Swing Shift)
Biogen
June 30, 2026
On-site
Triangle, NC
Operations
What You’ll Do
- Ensure disposition documentation (including batch and cell bank disposition) is compliant and determine acceptability for use in cGMP production and/or release for further processing or distribution (e.g., review/approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, FRRV/BOM, MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; manufacturing floor record reviews/observations, WORCs, inspection readiness walkthroughs, and oversight).
- Support resolution of low-complexity technical and compliance issues/gaps.
- Assist with CAPA assignment/closure based on CAPA intent understanding and review/approval of associated documentation (e.g., PRCD) at Management discretion/oversight.
- Support day-to-day implementation of Quality Management Systems to maintain cGMP compliance and ensure product safety/efficacy/purity; provide training within/across functions as applicable.
- Approximately 50% of time on the manufacturing floor.
- Other duties as assigned.
Required Skills
- Bachelor’s degree in life sciences or related.
- Minimum 2 years in a quality assurance role in a GMP pharma/biotech manufacturing environment.
- Ability to work independently and in teams across business areas and levels (locally and globally).
- Excellent written, verbal, and interpersonal communication skills.
- Familiarity with downstream process manufacturing.
Preferred Skills
- Prior GMP manufacturing experience.
- Experience with column packing or reviewing column pack binders.
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; fitness & wellness (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; 80 hours sick time/year; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Ensure disposition documentation (including batch and cell bank disposition) is compliant and determine acceptability for use in cGMP production and/or release for further processing or distribution (e.g., review/approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, FRRV/BOM, MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; manufacturing floor record reviews/observations, WORCs, inspection readiness walkthroughs, and oversight).
- Support resolution of low-complexity technical and compliance issues/gaps.
- Assist with CAPA assignment/closure based on CAPA intent understanding and review/approval of associated documentation (e.g., PRCD) at Management discretion/oversight.
- Support day-to-day implementation of Quality Management Systems to maintain cGMP compliance and ensure product safety/efficacy/purity; provide training within/across functions as applicable.
- Approximately 50% of time on the manufacturing floor.
- Other duties as assigned.
Required Skills
- Bachelor’s degree in life sciences or related.
- Minimum 2 years in a quality assurance role in a GMP pharma/biotech manufacturing environment.
- Ability to work independently and in teams across business areas and levels (locally and globally).
- Excellent written, verbal, and interpersonal communication skills.
- Familiarity with downstream process manufacturing.
Preferred Skills
- Prior GMP manufacturing experience.
- Experience with column packing or reviewing column pack binders.
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; fitness & wellness (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 paid holidays + 3 personal significance days; 80 hours sick time/year; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.