Job Description
Job Summary: The Coordinator-TCT/GMP Quality Assurance oversees quality assurance and regulatory compliance activities for LLUH TCT/GMP Laboratory, ensuring adherence to FDA, FACT, IRB, and other applicable standards. This role manages the Quality Management System (QMS), including SOPs, audits, CAPA programs, inspection readiness, regulatory submissions, staff training, and accreditation support. The coordinator collaborates with laboratory leadership, investigators, and institutional stakeholders to support compliant cellular therapy manufacturing operations, while also leading process improvement initiatives, monitoring supplier and material quality, preparing compliance reports, and providing operational support for TCT/GMP production and quality control activities as qualified. Performs other duties as needed.
Education and Experience: Bachelor's degree in Life Sciences or an equivalent field of study required. Master's degree preferred. Five years of experience as a Quality Specialist or Coordinator, within regulated clinical, blood or tissue banking or manufacturing environment preferred.
Knowledge and Skills: In-depth knowledge of laboratory safety standards, GxP compliance, and Quality Management Systems (QMS) in a regulated laboratory environment. Comprehensive knowledge of laboratory operations and understanding of cell therapy manufacturing, processing, quality control testing, and product release. Familiarity with regulatory and accreditation standards, including FDA, FACT, IRB, IND/IDE, and other applicable federal and institutional requirements. Able to speak, read and write legibly in English with professional quality; use computer and software programs necessary to the position (e.g., Microsoft Office, document control, quality management and laboratory information management systems, if applicable). Able to demonstrate excellent planning and organization skills; analyze and interpret complex information; prioritize work and resources; define problems and solutions; make recommendations; manage time effectively. Able to relate and communicate positively, effectively, and professionally with others; be assertive and consistent in following and/or enforcing policies; work calmly and respond courteously when under pressure; collaborate; accept direction; think critically; work independently with minimal supervision; perform basic math functions and statistical functions; manage multiple assignments effectively; problem solve; recall information with accuracy; pay close attention to detail. Able to distinguish colors as necessary; hear sufficiently; see adequately to read computer screens, and written documents necessary to the position.
Licensures and Certifications: California Clinical Laboratory Scientist License preferred.
