Associate III, Quality Assurance

Biogen • Research Triangle Park, NC

2d

About The Position

As a QA Associate III, you will apply strong knowledge of cGMP requirements, Biogen Quality Systems, internal procedures and your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports 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 identify and resolve quality and compliance concerns, support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support, including root cause and impact assessments, and may complete selected minor investigation or GCC assessment activities after demonstrating the required competencies and with management oversight. This individual contributor role requires sound judgment, mature situational leadership and the ability to work independently while collaborating across functions and organizational levels.

Requirements

• Bachelor’s Degree , preferred in a life science discipline
• 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
• Understanding of quality systems, quality concepts and manufacturing processes
• Strong organization, prioritization and multi-tasking skills
• Excellent written, verbal and interpersonal communication skills

Nice To Haves

• Investigation, root cause analysis, impact assessment and technical writing skills including demonstrated competency in minor investigations, CAPA documentation or GCC assessments
• Experience reviewing controlled manufacturing and disposition documentation
• Understanding of biopharma or pharma manufacturing processes

Responsibilities

• Review and approve batch and cell bank disposition documentation for cGMP compliance and 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 of manufacturing operations and technical consultation on regulatory and site-procedure requirements
• 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
• Assist with implementation of Quality Management Systems and GxP quality-systems training
• Communicate quality issues, recommendations and decisions across Quality, Manufacturing, Engineering, Warehouse, and other functions

Benefits

• Medical, Dental, Vision, & Life insurances
• 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)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level