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Associate II, Quality Control

Company: Biogen
Location: Bahama
Posted on: January 16, 2022

Job Description:

Job Description

About This Role:

Responsibilities of the QC Associate II include, but are not limited to performing raw material testing, acting as a liaison for transfer, validation and/or qualification activities, and robust and compliant cGMP documentation practices. A fundamental understanding of the Biogen Quality Systems and the ability 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

The QC Associate II will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology.

Qualifications

Required Skills

Education: 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
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

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.

Keywords: Biogen, Durham , Associate II, Quality Control, Other , Bahama, North Carolina

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