Associate II, Quality Control - Research Triangle Park, United States - Biogen

Description

The Associate II, Quality Control is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen manufacturing facility.

What you'll do:

• Perform testing including (but not limited to):
• Membrane filtration bioburden
• Kinetic turbidimetric assay (KTA) and kinetic chromogenic (KCA) endotoxin
• Growth promotion testing (GPT)
• Biological Indicator testing
• Microbial identification

The Associate II responsibilities include, but are not limited to, training, testing support for drug substance and drug product, support for qualification and validation activities as appropriate, robust, and Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions.

Additional responsibilities include adherence to all GLP/GMP requirements, a basic understanding of FDA/EMA regulations. The Associate II should have effective interactions/communication with Quality management. Associate will support investigations impacting the QC department and perform and document routine testing activities and laboratory inventory/maintenance, as needed.

Who You Are:

You are eager to learn and have great attention to detail. You operate with integrity and enjoy working in a collaborative environment. You have excellent communication skills, logical 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.
• Understanding of scientific principles, ability to communicate with peers and management.
• Ability to perform color differentiation testing.

Preferred Skills:

• GMP/GDP experience
• Effective organizational skills.
• Ability to coordinate multiple activities in parallel to meet required timelines.
• Ability to work independently and as part of a team.
• Solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g. strong test method/scientific base).
• Strong technical writing skills.

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.