Job Description

This position is on site, M-F business hours. There is a rotational on-call requirement (once a month, weekend on-call).

The Quality Assurance Associate III is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Bio facility. The responsibilities of the QA Associate III include but are not limited to, performing timely issuance and review of GMP documents (Standard Operating Procedures, Master Production Records and Solution Records, labels, and logbooks), support review and approval of change controls, deviations and CAPAs for compliance to applicable regulatory and corporate guidance documents, support the generation of metrics, revise/author GMP procedures, develop and perform basic GxP related training, assist in the preparation and performance of regulatory inspections, and identify gaps in existing Quality systems and propose solutions to site management. 

What You'll Do

• Issuance of batch documentation, label, and logbooks 
• Review and approval of batch related documentation (Logbooks) 
• Support and approve Quality, equipment, and systems related exceptions (deviations, lab exceptions, CAPAs) and change controls 
• Supports resolution of technical and compliance issues/gaps of mild to moderate complexity  
• 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 safety, efficacy and purity of products manufactured by Biogen 
• Complete and maintain related GMP training 
• Additional job duties that may be assigned from time to time

Qualifications

• Bachelor’s degree required, preferably in a field of science or biotechnology
• A minimum of 2 years relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation (GMP experience required)
• General understanding of relevant FDA/EMA regulations 
• Plans schedules and arranges own activities when accomplishing objectives 
• Must be able to deal with ambiguity 
• General understanding of Quality concepts; able to practice and implement them 
• Ability to develop innovative/creative solutions to issues of moderate complexity 
• Detail oriented aptitude 
• Excellent oral and written communication skills 

Preferred Skills

• Experience with deviations and change controls
• Experience working with metrics and complying with Data Integrity principles
• Experience with implementation of quality systems, Veeva experience would be helpful

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.