SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to treat blood cancer, aiming to improve survival rates and reduce risks associated with traditional allogeneic stem cell transplants. The company operates a state-of-the-art 100,000-square-foot manufacturing facility in Sacramento, CA.
The Specialist I, Quality Assurance role is central to maintaining quality standards across manufacturing operations. Key responsibilities include:
• Managing quality systems including deviations, change control, corrective and preventive actions (CAPA), and document management
• Overseeing production records and deviation system management to ensure compliance with quality policies
• Making timely batch disposition decisions to ensure quality standards are met before product release
• Supporting rapid processing timelines required by the company's cell therapy products
• Contributing to the advancement of the clinical pipeline and future commercial availability of life-saving therapies
This is an individual contributor role focused on quality assurance operations within a regulated biotech manufacturing environment. The ideal candidate will have experience with quality systems management, regulatory compliance, and batch release processes in a GMP manufacturing setting. The role offers the opportunity to directly impact patient outcomes by ensuring the highest quality standards for cell therapy products.
