Associate II, Quality Control
About This Role
The Quality Control Associate II is responsible for supporting key functional, tactical, and operational aspects of the QC Microbiology group at the Biogen RTP facility. An Associate II should possess a fundamental understanding of the Biogen Quality Systems and apply it in their daily support functions. Adherence to all cGMP requirements, a basic understanding of FDA/EMA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.
The schedule for this position will be Sunday through Wednesday, (4) ten hour shifts..
What You’ll Do
Perform release and stability microbial testing, include but are not limited to: membrane filtration bioburden, kinetic turbidimetric assay (KTA) endotoxin, growth promotion (GP) testing and all preparatory and post-execution activities associated with these testing in a cGMP manner
Perform analytical data review and trending
Support qualification and validation activities
Author action excursions, CAPAs, deviations and Quality Technical Reports
Who You Are
You have a passion for working in a laboratory and enjoy using your technical knowledge and data to drive key business decisions. You have an enthusiasm for learning new skills and being solutions oriented.
- Minimally BA/BS degree with 1-2 years of relevant industry experience required
- Good working knowledge of QC systems and operations
- Ability to multi-task and coordinate multiple activities in parallel, demonstrate problem solving and troubleshooting skills
- Work effectively within in a team enviroment
- Experience with LabWare LIMS and TrackWise
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.