Manager-TCT/GMP Quality Control Lab

Job Summary: The Manager-TCT/GMP Quality Control Lab leads the quality control function within LLUH TCT/GMP Laboratory. This position oversees the day-to-day activities and operations of the QC laboratory for preanalytics, analytics, and/or post-analytics of TCT/GMP manufactured products. This role provides leadership, technical expertise and hands-on support for the qualification and execution of QC testing methods, as well as the proper procedures and documentations for material release and product disposition. This includes establishing quality control documentation process, perform risk assessments, manage audits, and drive process improvement initiatives to adhere with regulatory agency and FACT accreditation guidelines. The quality control manager will work closely with clinical scientists, product development and manufacturing specialist, as well as multi-disciplinary clinical teams (physicians, nurses, other hospital staff) to support the TCT Clinical Program. Reports to the Director-TCT/GMP Laboratory Operations. Performs other duties as needed.

Education and Experience: Bachelor's degree in the life sciences, pharmaceutical sciences, or related discipline required. Master's degree preferred. Five years of experience as a clinical scientist, lab coordinator, or QC specialist within a cGxP environment in industry or academic institutions required. Two years of supervisory experience required.

Knowledge and Skills: Knowledge of cell biology, immunology, molecular biology, and cell-based analytical methods. Understanding of GMP, GLP, ICH guidelines and FACT accreditation standards related to quality control. Proficient in data analysis and analytical methods used for cell and gene therapy products such as cell counters, flow cytometry, PCR, ELISA, and microbiological testing. Knowledge in quality management systems (QMS) with experience related to method development/validation, deviation, OOS, CAPA, and change control. Proven leadership skills and the ability to take on increasing responsibility in complex environments. Able to: read; write legibly; speak in English with professional quality; use computer and software programs necessary to the position; troubleshoot and calibrate patient care equipment. 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. Able to communicate effectively in English in person, in writing, and on the telephone; think critically; work independently with minimal supervision; perform basic math functions; manage multiple assignments effectively; work well under pressure; problem solve; organize and prioritize workload; recall information with accuracy; pay close attention to detail. Able to distinguish colors and smells as necessary for patient care; hear sufficiently for general conversation in person and on the telephone; identify and distinguish various sounds associated with the workplace; see adequately to read computer screens, medical records, and written documents necessary to position; discern temperature variances through touch.

Licensures and Certifications: California Clinical Laboratory Scientist (CLS) License preferred.