Posted in Information Technology about 4 hours ago.
Type: Full Time
Location: Research Triangle Park, North Carolina
Job Description
This is a full time, on-site position
About This Role
The Senior Associate III in the Quality Systems organization is responsible for understanding quality systems, contributing to oversight of quality systems, and maintaining GMP activities at the Biogen Research Triangle Park (RTP) facility. They should be proficient in their understanding of the quality systems and apply that knowledge in coaching and continuous improvement.
The primary responsibilities of the Senior Associate III in the Quality Systems team include quality compliance for managing DS (Bio) site inspections, completing regulatory requests for partner and Biogen products, authoring Site Reports (Site Management Review Report and Site Master File), change control support, and the review and approval of site-specific GMP documents (Work Instructions, Master Production Records, and Solution Records) for compliance to applicable regulatory and corporate guidance documents, and consistency with business source documentation.
What You'll Do
Qualifications
Preferred Skills
Additional Information
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 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.
PDN-9d256412-8d98-4630-b34d-a2ed2027f9fe
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Biogen
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