Quality Assurance Specialist-TCT/GMP

Loma Linda University Health • Loma Linda, CA

1d

About The Position

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. The specialist leads and supports the design, development, and implementation of the laboratory’s quality management systems and processes. They monitor laboratory activities, review documentation, manage deviations and CAPAs, support audits and inspections, and identify opportunities for continuous improvement. The role helps ensure cell therapy products are consistently manufactured, tested, and released in accordance with established quality and safety requirements. Performs other duties as needed.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, or a related scientific or technical field.
• Three years of experience in Quality Assurance, Quality Control, cell therapy/cellular manufacturing, or a related GMP-regulated environment.
• Knowledge of laboratory safety standards, GMP compliance, and Quality Management Systems (QMS) in a regulated laboratory environment.
• Understanding of 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.
• Ability to speak, read, and write legibly in English with professional quality.
• Ability to use computer and software programs necessary to the position, such as Microsoft Office and, if applicable, document control, quality management, and laboratory information management systems.
• Excellent planning and organization skills; ability to analyze and interpret complex information, prioritize work and resources, define problems and solutions, make recommendations, and manage time effectively.
• Ability to communicate positively, effectively, and professionally; collaborate; accept direction; work independently with minimal supervision; and remain calm and courteous under pressure.
• Ability to be assertive and consistent in following and/or enforcing policies.
• Ability to think critically, perform basic math and statistical functions, manage multiple assignments, solve problems, recall information accurately, and pay close attention to detail.
• Ability to distinguish colors as necessary, hear sufficiently, and see adequately to read computer screens and written documents necessary to the position.

Responsibilities

• Provide quality oversight for the TCT/GMP Laboratory.
• Lead and support the design, development, and implementation of laboratory quality management systems and processes.
• Monitor laboratory activities and review documentation.
• Manage deviations and CAPAs.
• Support audits and inspections.
• Identify opportunities for continuous improvement.
• Help ensure cell therapy products are manufactured, tested, and released in accordance with established quality and safety requirements.
• Perform other duties as needed.

What This Job Offers

• Job Type: Full-time