Associate I, Quality Control

Job Description

Job Description: Responsibilities of the QC Associate I include, but are not limited to, training, testing support, inspections, 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.

Core Responsibilities:

• Performs routine environmental monitoring sampling.
• Performs routine testing activities, 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, Plate reading, and Growth Promotion. 
• Provides timely review of data and documentation generated for or by QC.
• May perform document revisions.
• Participates in the execution of method/material qualification and analytical improvement projects.
• Supports maintenance of laboratory systems and inventory of standards and reagents to ensure integrity of all laboratory results.

Qualifications

B.S. Degree and 0-3 years of relevant experience OR A.S. degree and 2+ years of relevant experience.

The QC Associate I will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology. The position requires but is not limited to the following:

• Understanding of scientific principle, ability to communicate with peers and management; 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
• Demonstrated problem solving skills
• Solid working knowledge of operations/quality systems utilized in QC operations/support teams (eg; strong test method/scientific base)
• Strong technical writing skills

Additional Information

All your information will be kept confidential according to EEO guidelines.

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.