Quality Assurance Specialist-TCT/GMP

Job Summary: The Quality Assurance Specialist-TCT/GMP provides quality oversight for the TCT/GMP Laboratory, ensuring technical operations comply with applicable regulations, FACT accreditation standards, institutional policies, and established quality requirements. This position will lead and support the design, development, and implementation of the laboratory’s quality management systems and processes, while monitoring laboratory activities, reviewing documentation, managing deviations and CAPAs, supporting audits and inspections, and identifying opportunities for continuous improvement. The specialist helps ensure cell therapy products are consistently manufactured, tested, and released in accordance with established quality and safety requirements. Performs other duties as needed.

Education and Experience: Bachelor’s degree in Life Sciences, Biotechnology, or a related scientific or technical field required. Three years of experience in Quality Assurance, Quality Control, cell therapy/cellular manufacturing, or a related GMP-regulated environment required. 

Knowledge and Skills: Knowledge of laboratory safety standards, GMP compliance, and Quality Management Systems (QMS) in a regulated laboratory environment. Understands laboratory operations and 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: None.