3 cellular therapy qa specialist jobs found

DescriptionIn this role you will: Provide guidance to maintain a quality and compliance program within the Bone Marrow Stem Cell Lab, Hemapheresis Unit and Hematologic Malignancies/Stem Cell Transplantation (HM/SCT) Adult and Pediatric Clinical Program. Duties include but are not limited to: * Maintain Quality System Essentials throughout an active Cellular Therapy program, Hemapheresis Unit and Stem Cell lab operation * Ensure compliance with all regulations, guidelines, and standards of the licensing accrediting credentialing and regulatory agencies with particular focus on FDA guidelines for Current Good Tissue Practices, HCT/Ps and FACT * Ensure adherence to UCLA internal policies for safety and corporate compliance. * Serve as QA and regulatory resource department wide within the framework of a QA and compliance unit * Activities of a quality program include: o Development, maintenance, review and approval of SOPs, training programs, competency assessment...

The Division of Hematology and Oncology in the Department of Medicine, at the University of Virginia School of Medicine, is seeking a Clinical Lab Specialist II. Clinical Lab Specialist 2 employees provide manufacturing of clinical cGMP products for administration to patients with cancer or other immune diseases. They also provide technical lab support by performing complex immune testing to evaluate patient samples for immune responses with minimal or no supervision. They act as specialists in clinical manufacturing and research methods and manage equipment functions specific to investigations. They will attend education for cGMP manufacturing of cell products and processing of clinical products. They are distinguished from Lab Technicians by their training and skills in manufacturing FDA-approved clinical products for the treatment of patients with cancer and other immune diseases. They maintain the skills and expertise necessary to serve as a resource on non-routine...

The Division of Hematology and Oncology in the Department of Medicine, at the University of Virginia School of Medicine, is seeking a Clinical Lab Specialist 1. Clinical Lab Specialist 1 employees provide manufacturing of clinical cGMP products for administration to patients with cancer or other immune diseases. They also provide technical lab support by performing immune testing for the release of products under the supervision of the cGMP supervisor or designee by the medical or scientific director. They will attend education for cGMP manufacturing of cell products and processing of clinical products. They act as specialists in clinical manufacturing and assist in the maintenance of equipment functions, implementation of SOPS, and performing tasks to insure the cGMP facility meets operational standards. They are distinguished from Lab Technicians by their training and skills in manufacturing FDA-approved clinical products for the treatment of patients with cancer and...