QC Specialist III
About The Position
This position is for Sun-Wed Swing Shift, 12:00PM to 10:30PM. Primary Job Responsibilities: • Lead (or support) projects in Analytical Method development, validation, and method technology transfer in areas of Flow Cytometry, ddPCR and Bioassays consisting of cell culture and ELISA. • Lead (or support) studies, implementation of new processes or technologies, and revise or review SOPs, qualification/validation protocols and reports. • Perform analytical assays in techniques such as Flow cytometry, ddPCR, cell culture and ELISA GMP environment. • Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays. • Support audit activities and regulatory inspections by assisting in preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, if needed. • Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate. • Lead investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory. • Support generation of trending charts for monitoring method performance, product quality, invalid rate and/or stability. • Perform QC sample receipt, processing, and distribution for testing and storage as well as track inventory of lab supplies and materials. • Monitor the GMP systems currently in place to ensure compliance with documented policies • Support generation of CoAs for product release as needed. • Mentor and support on the job training for junior staff.
Requirements
- 5+ years of relevant experience and a BS or BA.
- 3+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
Responsibilities
- Lead (or support) projects in Analytical Method development, validation, and method technology transfer in areas of Flow Cytometry, ddPCR and Bioassays consisting of cell culture and ELISA.
- Lead (or support) studies, implementation of new processes or technologies, and revise or review SOPs, qualification/validation protocols and reports.
- Perform analytical assays in techniques such as Flow cytometry, ddPCR, cell culture and ELISA GMP environment.
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
- Support audit activities and regulatory inspections by assisting in preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, if needed.
- Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate.
- Lead investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory.
- Support generation of trending charts for monitoring method performance, product quality, invalid rate and/or stability.
- Perform QC sample receipt, processing, and distribution for testing and storage as well as track inventory of lab supplies and materials.
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Support generation of CoAs for product release as needed.
- Mentor and support on the job training for junior staff.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
