QC Specialist

Role Summary

QC Specialist responsible for performing GMP-compliant release and stability testing for cell therapy products and in-process samples, maintaining lab equipment and supplies, and supporting quality control investigations and data trending.

Responsibilities

• Execute GMP-compliant release and stability testing for cell therapy products and in-process samples using flow cytometry, PCR, ELISA, sterility, mycoplasma, and endotoxin methods.
• Contribute to drafting SOPs, forms, and logbooks governing the upkeep, calibration, and preventive maintenance of lab equipment and instruments.
• Coordinate maintenance activities for equipment and instruments with internal resources and external partners.
• Manage inventory of lab supplies and materials.
• Support GMP investigations, out of specification test results, invalid assays, deviations, change controls, and CAPAs.
• Support tracking and trending of QC data.

Qualifications

• Required: BS or MS in biological sciences or a related field.
• Required: 5+ years of pharmaceutical or biotechnology industry experience, including experience in cell therapy.
• Preferred: Previous experience performing PCR and/or Flow Cytometry based assays.
• Required: Excellent written and oral communication skills.

Education

• BS or MS in biological sciences or a related field.

Additional Requirements

• No additional travel, physical demands, or other requirements specified as essential in the provided content.