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Analyst I, Quality Control - Molecular Biology
Woburn, MA 02139 US
Adaptable to perform in a fast-paced environment while still delivering high-quality results, this Analyst I - QC Molecular Biology will be required to have strong interpersonal skills and be able to work under minimal supervision.
- Performs routine QC testing including, but not limited to: ddPCR/dPCR and qPCR test methods in support of in-process, release, and stability.
- Supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
- Support development, technical transfer and validation of qPCR and ddPCR-based assays and other methods for lot release and stability as needed.
- Authors and Revises SOPs/Forms and other relevant controlled documentation.
- Performs peer review of both internal and externally generated data.
- Support QC deviations, investigations, analytical method performance trending and root cause analysis, as needed.
- Ensures laboratory inspection readiness and assists with troubleshooting/continuous improvement as needed.
- BS or MS in Molecular Biology, Cell Biology, Biochemistry or a related discipline with 2+ years industry experience. QC GMP experience is required.
- Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution required.
- Experience with statistical analysis of analytical data and stability studies preferred
- Experience with viral vectors is not required but experience with biologics preferred
- Ability and desire to work in a fast-paced, start-up environment
- Strong collaboration, team-working skills and communication skills
- Independently motivated and detail-oriented with good problem solving ability