Kyverna - Therapeutics - Senior Specialist, Quality Assurance Operations (Contract)
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Requirements
• Bachelor’s degree in a life sciences discipline (e.g., biology, immunology, biochemistry) or equivalent experience • Minimum of 6 years of experience in Quality Assurance or a related role within biotech, pharmaceutical, or cell/gene therapy industries • Strong ability to manage multiple priorities in a fast-paced environment with keen attention to detail
Responsibilities
• Review executed batch records and associated documentation for accuracy and compliance • Support batch release and disposition activities • Must consistently meet production schedule release timelines • Ability to identify and escalate issues to Quality Management • Provide quality guidance on documentation discrepancies and compliance issues • Maintain and update vendor change notifications tracker • Assist with quality system processes, including deviations, change controls, CAPAs, and vendor change notifications • Ensure adherence to cGMP regulations, ICH guidelines, and Kyverna SOPs • Contribute to quality system enhancements and continuous process improvement initiatives • Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels
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