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Associate II, QC Raw Materials

Company: Biogen
Location: Bahama
Posted on: January 15, 2022

Job Description:

Job Description

Responsibilities of the QC Associate II include, but are not limited to, testing support for dual sourcing, 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.

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 and Osmolality.
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

You are a problem solver and team player who possesses demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology.

Required

Qualifications
3-5 years of relevant experience (B.S. Degree), 7+ years of relevant experience (A.S. degree in biological science)
Understanding of scientific principle, ability to communicate with peers and management; GMP/GDP experience
Solid working knowledge of operations/quality systems utilized in QC operations/support teams (eg; strong test method/scientific base)
Strong technical writing skills

Preferred
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

Additional Information

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.

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

Keywords: Biogen, Durham , Associate II, QC Raw Materials, Other , Bahama, North Carolina

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