Associate III, Quality Assurance

About This Role

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.

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.

• 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

You are a detail-oriented quality professional who applies sound judgment, regulatory knowledge and a practical understanding of manufacturing to protect product quality. You communicate complex information clearly, adapt to changing priorities and build productive cross-functional partnerships to resolve issues and maintain compliance.

• Bachelor’s Degree required, 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

• 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

Job Level: Professional

The base compensation range for this role is: $69,000.00-$90,000.00

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.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

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