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Form of workAbout This Role
The Quality Assurance Associate II is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identifying gaps in existing Quality systems and proposing solutions to site management. The QA Associate will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures and also adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers, and coordination of investigations impacting the RTP site. The QA Associate may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. The QA Associate will also ensure compliance with training policies.
Please note that this is a Swing Shift position and will work a traditional 2-2-3 Manufacturing Rotation from 12pm to 12am, on a 12hr/shift schedule. There is a 10% pay differential for this position.
What You'll Do
- Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols, and reports) to support product disposition.
- Execute activities including intermediate technical writing, minor investigation support (root cause analysis/impact assessment)
- Support resolution of both technical and compliance issues/gaps of moderate complexity. Aide in implementation of Quality Systems/System Improvements with guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
- Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
- Control and release of equipment from maintenance, validation, change control and product changeover.
- Support and/or assists in GxP quality systems-related training. Provide quality guidance across functions.
Who You Are
The ideal candidate is curious, eager to learn, asks directed questions, and challenges assumptions. Additionally, the candidate has excellent communication/collaboration skills, logical and evidence-based thinking, and can work across all levels of the organization.
- Bachelor's degree preferably in a field of science or biotechnology.
- 0-2 years relevant technical experience in quality oversight preferably in a biotech or pharmaceutical manufacturing operation.
- General understanding of relevant FDA/EMA regulations.
- Plans schedule and arranges own activities when accomplishing objectives.
- Must be able to deal with ambiguity.
- General understanding of Quality concepts; able to apply to process decisions
- Ability to develop innovative/creative solutions to issues of moderate complexity.
- Detail oriented.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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 DE&I efforts.
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.
