Associate II, Quality Control

Job Description

• Performs release and stability testing and all associated activities associated with this testing.
• Responsibilities include, but are not limited to, training, testing support for release and stability, support for transfer qualification/validation activities as appropriate, robust and compliant cGMP documentation practices.
• A fundamental understanding of the Biogen Quality Systems and able to apply it in their daily support functions.
• Adherence to all GMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.
• Able to work effectively within the group.

Qualifications

• Minimally BA/BS in Life Sciences with 1-2 years of relevant industry experience required.
• Understanding of basic scientific principle, ability to communicate with peers and management, effective organizational skills
• Ability to multi-task and coordinate multiple activities in parallel, developing or demonstrated problem solving skills, developing or demonstrated instrument/method troubleshooting skills, and has good working knowledge of operations/quality systems understands work processes of QC operations/support teams (ex: strong test method/scientific base).
• Completes deliverables within targeted time frames with good quality, and the individual is able to draw conclusions from data interpretation.
• Solid technical writing skills, authors reports with input & guidance and conducts compliance/work impact assessments as appropriate.
• Works on process improvements, actively supports management & QC teams.

Additional Information

The QC Associate II is responsible for supporting key functional, tactical, and operational aspects of the QC Chemistry group at Biogen.