SRG is seeking a Senior QC Analyst for a client in Berkeley, CA.
This position is with a major pharma company, and qualified candidates should have a BS in Chemistry, Biochemistry, or a related field, and 4+ years of related industry experience in a cGMP environment.
Note that this position will be on night shift following the initial training period.
- Perform activities associated with cGMP quality release and stability testing of rFVIII products, including reagent qualification, performing instrument calibration, performing hands on testing and review, archiving cGMP documents, and activities to maintain the laboratories in a compliant status
- Perform cGMP testing and review of data and perform activities to maintain the laboratory in a state of compliance
- Perform testing and data review for release, stability, and reagent qualification
- Execute potency testing and review
- Perform instrument maintenance
- Report and review data in LIMS and SAP systems and routinely archive data
- BS/BA in Chemistry, Biochemistry, Chemical Engineering, or a related field
- 4+ years of related industry experience working in a cGMP regulated environment
- Experience with robotic platform (Hamilton) and/or Hematology instrumentation (such as ACL TOP 500)
- Background in biochemistry, specifically in rFVIII Potency testing and data analysis of rFVIII product.
- Knowledge on data integrity is required in areas such as following procedures / protocols, data recording rules, and data archiving.
- Ability to work graveyard hours
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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