Performs testing, and all associated activities associated with this testing. Responsibilities include, but are not limited to, training, testing support, support for qualification/validation/certification 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, effective interactions/communication with Quality management, personal development, and support of investigations. Able to work effectively within the group.
This position will entail four (4) 10-hour shifts providing coverage for Thursday through Sunday.
The Quality Control Associate I / II will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology. The position requires but is not limited to the following:
- Understanding of basic biological science principles
- Ability to communicate with peers and management
- Effective organizational skills
- Ability to multi-task and coordinate multiple activities in parallel
- Developing or demonstrated instrument/method troubleshooting and problem solving skills
- General knowledge of FDA/EMEA regulations and compliance
- The ability to work four (4) 10-hour shifts providing coverage for Thursday through Sunday.
- Experience with Environmental Monitoring, Water Collection, and cGMP experience preferred
Associate I Requirements:
0-2 years of relevant experience (B.S. degree) 2+ years of relevant experience (A.S. degree).
Associate II Requirements:
2+ years of relevant experience (B.S. degree) 4+ years of relevant experience (A.S. degree).
Employment CategoryFull-Time Regular