Associate III, Quality Assurance

About This Role

The Quality Assurance (QA) Associate III is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Substance facility. The QA Associate III may participate in internal compliance audits; assess and approve discrepancies from site, corporate, and regulatory guidance. The QA Associate III will also support leadership for activities related to interviewing and training of employees, as well as compliance with training policies.

What You’ll Do

• Review and approve batch related documentation (cGMP procedures, Master Production Records, Solution Lot records) to support drug substance disposition.
• Execute activities including intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity).
• Support resolution of both technical and compliance issues/gaps of moderate complexity. Aide in implementation of Quality Systems/System Improvements with some 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.
• Support and/or assist in GxP quality systems-related training. Provides some mentorship and training within and across functions.

Who You Are

You are curious and eager to learn. You ask copious questions and accept nothing at face value without evidence. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

• Bachelor’s degree preferably in a field of science or biotechnology.
• A minimum of 2 years relevant technical experience in quality oversight of a biotech or pharmaceutical manufacturing operation.
• General understanding of relevant FDA/EMA regulations and compliance.
• Strong organizational skills.
• Must be able to deal with ambiguity.
• General foundation 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 in DS manufacturing operation.
• Additional years of experience in quality.

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.