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Senior Quality Control Analyst
3 months ago
We are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.), flow cytometry platforms, as well as cell count/viability determinations using the NC-200 platform. This position will support the ramp up of QC and other activities in a newly built facility for cell therapy products.
Essential Functions and Responsibilities
- Act as a technical subject matter expert (SME) for potency and flow testing activities
- Mentor and train new laboratory personnel
- Perform daily GMP Quality Control laboratory testing activities at the facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
- Perform data analysis and final result reporting to support product lot release with adherence to turnaround times
- Perform all activities with respect to GMP/GDP compliance.
- Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
- Support thorough GMP investigations for out of specification test results and other quality events (initiate DRs and LIRs)
- Support technical problem solving for issues pertaining to GMP Quality Control
- Support product stability programs including execution of stability testing and stability data analysis
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Perform peer and/or technical review of laboratory data and logbooks
- Analysis of assay-specific analytical performance trending
- Support Health Authority inspections
- Provide input to functional laboratory and cross functional team meetings
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
- Other responsibilities as assigned
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
- Minimum five (5) years of experience in the pharmaceutical industry within a GMP Quality Control role
- Experience with Flow Cytometry and/or Cell based ELISA platforms
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive, changing timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
