Quality Control, Scientist
19 Presidential Way, Suite 202 Woburn, MA 01801 US
Job Description
o Support the establishment and management of stability programs for the above-mentioned banks by preparing stability protocol, scheduling the testing with Contract Testing Labs, reviewing data, and writing study reports.
o Lead QC deviations, investigations, and root cause analysis, change control and CAPA activities related to plasmid and E. coli banks
o Work independently to review and trend QC data, generating stability and other trending reports as necessary.
o Support the development of QC systems and SOPs, to enable in-house QC release testing.
o Work with cross functional teams and support regulatory filing when needed.
Required:
cGMP experience
4+ years related to plasmid or E. coli manufacturing
Pay $50-68/hr based on experience level
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