Senior Quality Control Specialist
7 days ago
The Quality Control Specialist will support critical analytical method implementation workstreams in support of GMP testing laboratory start-up plan. This role will serve as a Subject Matter Expert in the quality control group and lead the training efforts, method transfers from external CDMO, Analytical R&D to QC group.
Key Responsibilities- Maintain QC laboratory including instrument calibration, PMs, and operational SOPs
- Perform Release Testing, Qualification, Validation and Method Transfer for various cell therapy methods
- Perform stability testing, assist, keep records of stability sample pulls, and write/revise stability protocols
- Train junior QC Analysts
- Collaborate with multiple departments for on-time completion of variety of analyses
- Process improvement for a faster turnaround time, OTIF (on-time in full) completion of projects
- Prepare the data packet for review and peer-review the data
- Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors
- Support stability data analysis along with stability document reviews
- Track and order laboratory reagents and materials
- Sample receiving per the BEAM-SOP guideline
- Oversee general cleaning and upkeep of the laboratory and equipment
- Bachelor's degree required, preferably in a chemistry, life science, or related discipline
- 10+ years relevant experience
- Prior GMP experience
- Hands-on experience on with at least one of the following analyses: mRNA, LNP, CFU, Potency assay, gRNA, NGS assay, Flow Cytometry, PCR, ELISA, and/or Multiplex
- Hands-on experience with HPLC (DAD-CAD, UV-ViS), UHPLC, and/or Mass-Specs preferred
- Result-oriented and ability to prioritize complex issues
- Prior knowledge of LIMS, VEEVA, and/or KNEAT preferred
- Scientific knowledge and direct experience with analytical method transfer processes
- Advanced technical writing skills and problem-solving ability
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Collaborative with 'Team First' mentality
- Communicate effectively with peers, and demonstrate collaboration across different functional groups
Beam Therapeutics Inc.
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