Associate II, Quality Control

Job Description

Responsibilities of the QC Associate II include, but are not limited to, raw material testing support, protocol and report writing, robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions. The incumbent will be responsible for adherence to all GMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations. The incumbent should be able to work effectively within the group as well as independently to meet assigned timelines.  Operate with integrity.

What you’ll do:

• Perform routine release testing of Raw Materials, such as compendial analysis per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing, based on cGMP's and internal procedures. Testing includes, but is not limited to: Bioburden, Endotoxin, Titrimetry, pH, Solubility, FTIR, Specific Rotation, Osmolality and Utility Monitoring Testing (TOC, Conductivity, Nitrates).
• Provides timely review of data and documentation generated for or by QC.
• Participates in the execution of method/material qualification and analytical improvement projects.

Who You Are:

Good understanding of the operating principles for quality control testing. The ideal candidate is eager to learn, asks copious questions and accepts nothing at face value without evidence. Operates with integrity. Have great attention to detail. Additionally, the candidate has excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization.

Qualifications

•  0-2 years of relevant experience and B.S. Degree
• 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.

Additional Information

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.