QC Analyst II Job at Repligen
Overview:
The QC Analyst I or II will report directly to the QC Manager and will be primarily responsible for:
- performing in-process and final release testing of Repligen Bioprocessing ligands,
The analytical activities supporting performing tests such as ELISA, SDS-PAGE (including IEF), Analytical HPLC, UV analysis.
- The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the clean rooms as well as RODI collection and analysis.
- The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory responsibilities as assigned by the QC Manager.
- performing in-process and final release testing of Repligen Bioprocessing ligands, and
- release of OPUS pre-packed chromatography columns.
- ELISA
- SDS-PAGE Gel
- HPLC
- Collection of Environmental Monitoring data in the clean rooms as well as RODI collection and analysis.
- UV Analysis
- Writing Investigation for deviations and corrective actions
- Assisting with writing SOPS (includes reviewing and approving)
- Reviewing in-process and final release data
- support with training new analysts
- support with data trending for final product, RODI and EM
- For QC I : Undergraduate Degree in the Life Sciences (Biology, Biochemistry, Cell Biology, Genetics, Forensic science or related) with 0-2 years of experience in an academic or industry lab setting. Fresh graduates with no experience, but with relevant coursework and lab work in the above lab techniques will be considered.
- Ability to work independently once training has been completed
- High attention to detail applied to all aspects of daily activities
- Ability to work efficiently in an ISO 9001 quality system with appropriate attention to detail in the performance of controlled procedures
- Good understanding of the fundamentals of column chromatography. Experience with HPLC systems - Agilent ChemStation and AKTA chromatography systems a plus
- Experience in ELISA
- Experience in SDS-PAGE
- Experience or knowledge of FTIR a plus
- Familiarity with microbiology techniques such as aseptic handling of materials and working within a BioSafety Cabinet
- For QC II : All the above with 2+ years of experience.
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