Title: Senior Specialist, QA Operations
Location: Emeryville, CA (Hybrid)
Reports To: Sr Director, Quality Assurance Operations
Responsibilities- Review executed batch records and supporting documentation to ensure accuracy, completeness, and compliance with applicable requirements.
- Support batch disposition and product release activities while maintaining adherence to established timelines.
- Consistently meet production release schedules and quality deliverables.
- Proactively identify, investigate, and escalate quality and compliance issues to Quality Management.
- Provide quality oversight and guidance regarding documentation discrepancies, deviations, and compliance-related matters.
- Maintain and update the vendor change notification tracking system and support the monitoring of key quality and operational performance metrics.
- Partner with cross-functional teams to facilitate the timely assessment, implementation, and closure of vendor change notifications.
- Support quality system processes, including deviations, change controls, CAPAs, and vendor change management activities.
- Ensure compliance with cGMP regulations, ICH guidelines, and company SOPs and quality standards.
- Author, review, revise, and maintain SOPs and other controlled documents to standardize and improve business processes.
- Contribute to continuous improvement initiatives and enhancements to the Quality Management System (QMS).
- Support inspection readiness activities, internal and external audits, and perform additional responsibilities as assigned.
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
- 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
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
The national salary range for this position is from $110,000. to $135,000. USD annually. This salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company's stock plan.
