We are seeking an innovative and highly motivated Quality Control Specialist to join our Quality team. This contract role will have the primary focus of supporting external lot release testing, Contract Test Lab Management, stability studies management, and data trending.

QUALIFICATIONS

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• BS in biological sciences or a related field.

• 3 or more years of QC experience in a GMP environment.
• Strong attention to detail.
• Excellent written and oral communication skills.

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• Test record review for GMP-compliant release and stability testing for cell therapy products and in-process samples using flow cytometry, PCR, ELISA, sterility, mycoplasma, and endotoxin methods.

• Management of stability studies including collaboration with external test facilities, data entry, report generation and data trending.
• Support GMP investigations, out of specification test results, invalid assays, deviations, change controls, and CAPAs.
• Support tracking and trending of QC release data.