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. 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: Development, maintenance, review and approval of SOPs, training programs, competency assessment programs validation and revalidation plans and results record keeping and document control systems, corrective and preventive action plans, proficiency testing programs. Performs audits of operational functions. Review and evaluate reports of occurrences and adverse events. Collection and analysis of quality metrics. Application of process improvement tools and techniques.
UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.