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North Carolina, United States
Onsite
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.
What You’ll Do
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
Who You Are
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.
Required Skills
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
Preferred 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
Additional Information
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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
