Specialist, Quality Assurance

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� Description

• • Serve as the linchpin of Orca Bio’s Quality Assurance organization, owning the day-to-day operation of critical quality systems—deviations, change controls, CAPAs, and document control—that underpin the release of life-saving, high-precision cell therapies.
• • Make real-time, science-based batch-disposition decisions on every lot manufactured in our 100,000-square-foot, state-of-the-art GMP facility, ensuring that patients receive products that meet the industry’s most rigorous safety, identity, strength, purity, and potency standards.
• • Lead thorough, timely deviation investigations from initiation to closure: gather cross-functional data, identify true root causes using proven RCA tools, and drive the implementation of robust corrective and preventive actions that prevent recurrence and continuously elevate product quality.
• • Review and approve change controls with a risk-based mindset, partnering with Manufacturing, Process Development, Analytical Development, and Regulatory Affairs to evaluate the impact of proposed changes on product quality, regulatory filings, and patient safety.
• • Maintain and continuously improve the electronic and paper-based document management system, ensuring that SOPs, batch records, validation protocols, and regulatory submissions are accurate, current, version-controlled, and audit-ready at all times.
• • Serve as the primary QA point of contact during internal and external audits (FDA, notified bodies, partners), presenting quality systems data, managing commitments, and driving the timely completion of observations and CAPAs to maintain an inspection-ready state.
• • Generate and trend quality metrics (deviation rates, CAPA effectiveness, batch release cycle times, document on-time completion) to identify systemic issues, propose data-driven improvements, and report performance to senior leadership during monthly QSR meetings.
• • Provide hands-on training and mentoring to Manufacturing, QC, and Facilities personnel on GMP compliance, quality systems procedures, and documentation best practices, cultivating a culture where quality is everyone’s responsibility.
• • Collaborate closely with Manufacturing teams on the floor to resolve real-time issues, balance speed with compliance, and ensure that rapid processing timelines—critical for cell therapy viability—are met without compromising product integrity.
• • Champion continuous improvement initiatives such as Lean/Six Sigma projects, electronic system enhancements, and right-first-time programs that reduce waste, streamline workflows, and increase overall equipment effectiveness (OEE).
• • Support regulatory submissions and health authority interactions by authoring or reviewing CMC sections, responding to questions, and ensuring that quality commitments made to agencies are fulfilled and documented.
• • Maintain personal compliance with all gowning, safety, and environmental monitoring requirements; model adherence to cleanroom behavior standards and proactively address any breaches to protect product, personnel, and patients.
• • Flex between Orca Bio’s two Sacramento sites (3400 Business Dr. and 7910 Metro Air Pkwy) as operational needs dictate, ensuring seamless quality oversight across all manufacturing and testing activities.

� Requirements

• • Bachelor’s degree in biology, biochemistry, immunology, or related scientific discipline plus 3+ years of hands-on QA/QC or GMP manufacturing experience, OR Master’s degree in relevant discipline plus 1+ years of experience
• • Demonstrated understanding of FDA regulations (21 CFR Parts 211, 1271), EU GMP Annex 1, ICH Q7/Q10, and USP/EP compendial requirements as they apply to biologics or cell & gene therapy products
• • Proven track record managing deviations, CAPAs, change controls, and document management systems in an electronic Quality Management System (eQMS) such as Veeva, MasterControl, TrackWise, or equivalent
• • Experience conducting root-cause analysis using tools such as 5-Whys, Fishbone, FMEA, or Kepner-Tregoe and driving cross-functional teams to implement sustainable corrective actions
• • Ability to meet visual acuity and color-vision standards (20/20 corrected or uncorrected) and comply with full cleanroom gowning requirements for extended periods

️ Benefits

• • Competitive base salary of $75,000–$90,000 plus pre-IPO equity participation, giving you direct ownership in the success of transformative cell therapies
• • Comprehensive medical, dental, and vision coverage for you and eligible dependents, effective day one of employment
• • Flexible PTO policy and generous parental leave, supporting work-life balance as you help bring life-saving treatments to patients
• • Daily catered lunches, healthy snacks, and fully stocked kitchens at both Sacramento locations to keep you energized and connected with colleagues