Cell Therapy Quality Assurance Specialist

OrganaBio - San Diego, CA

Hiring: Cell Therapy Quality Assurance Specialist Company: OrganaBio Location: San Diego, CA Job Posted Time: 2026-09-03 10:23:45 Employment Type: Contract About the job Experience: •5+ years industry experience with in a GMP Quality or Manufacturing environment. Cell culture and aseptic processing experience preferred. Required Skills: •Adheres to, and trains team members on good manufacturing practices (GMP) guidelines. •Provides on the floor support to manufacturing team members - understands manufacturing steps per BPR and recognizes when deviations or incidents are to be documented. •Ensure aseptic processing techniques and appropriate cleanroom behavior are followed. •Perform room and line clearances in support of manufacturing schedule. •Must clothe in clean room gowns to work in a clean room environment. •Supports environmental monitoring processes defined by the facility and assists with troubleshooting. •Have experience in writing and/or revising Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and other Quality/Compliance related documents. •Review completed batch records for GMP compliance and completeness, compile information for disposition. Qualifications: •Must be able to stand long hours. •Must be able to gown up for cleanroom work. •Must be able to work in a warehouse environment. •Must be able to communicate clearly. •May be required to lift 20 pounds. •Exposed to Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, flow cytometers, incubators, bioreactors, cell separators). •Normal office equipment such as: telephone, computer, cell phone, printer, copier, fax, scanner. •General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, refrigerators, freezers). •Degree in biology or related field or equivalent combination of education, training and/or experience. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!