US-MA-Cambridge: Associate II, Quality Control
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Associate II, Quality Control
Job Description Key responsibilities and tasks include:
1. Support biological activity assays for product release/stability testing of various Biogen Idec pipeline programs.
2. Support routine laboratory systems and operations, including cell line maintenance.
3. Support qualification activities for data reduction software applications and sophisticated bioassay instrumentation.
4. Participate in method transfer/validation projects.
5. Author SOPs, qualification/validation protocols and reports.
6. Contribute to continuous improvement initiatives.
-2-4 years of relevant experience in a bioanalytical laboratory/environment (preferably cGMP regulated). Assay experience should include coagulation assays, ELISA and/or other cell-based assays.
-Aseptic technique and cell culture experience required.
-Hands-on experience with software and/or instrumentation qualifications desired.
-Demonstrated laboratory, computer, documentation/writing and organizational skills, as well as excellent communication skills.
-BS in Biology, Biochemistry, Microbiology or other related field of study.
Education Bachelor of Science degree in a biological science or related field (or equivalent combination of higher education and industry experience
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Team SQAFYI - Software QA Resource FYI