Senior Specialist, Quality Assurance Operations (Contract)

We are seeking a Sr. Specialist, Quality Assurance Operations (QA Ops) for a temporary assignment. The Sr. Specialist will provide quality expertise to support QA Operations in the development and commercialization of Kyverna’s products, ensuring compliance with applicable US, EU, and ICH regulatory requirements. The Sr. Specialist will contribute to the execution and continuous improvement of QA Operations as the organization continues to grow and evolve. This role requires strong collaboration with cross-functional teams, particularly in supporting batch record review and disposition activities. 

Title: Senior. Specialist, Quality Assurance Operations (Contract)
Reports to: Sr Director, Quality Assurance Operations 
Location: Remote or Hybrid (Emeryville, CA)
Duration: 6+ Months

Hourly Rate: $55–$65/hour (National)

• 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
• Perform additional duties as assigned

• 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
• Highly organized, self-motivated, and capable of working independently while following through on responsibilities
• Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels