Cell Therapy Quality Assurance Specialist
About the role
OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation. This position will work at the newly formed OrganaBio subsidiary Excellos Labs, LLC (“Excellos Labs”) located in Downtown San Diego, California. The Cell Therapy QA Specialist is responsible for supporting the production of various cellular products in a clean room manufacturing environment. The Specialist will be responsible for working in cGMP ISO7 and ISO8 manufacturing spaces and controlled, supportive laboratory and warehouse areas. The Specialist will be responsible for QA support including, but not limited to, on the floor QA support, document management, support disposition of raw materials and product, deviation/CAPA/change control approvals as well as oversight of material and product storage and distribution. The role operates in a normal laboratory environment with biohazard precautions, potential exposure to blood or bodily fluids, hazardous chemicals, and liquid nitrogen, and may require working outside regular hours, overtime, or through breaks. Physical demands include standing for long hours, gowning for cleanroom work, warehouse work, clear communication, and lifting up to 20 pounds. Equipment used includes laboratory processing equipment (centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, flow cyt