Quality Assurance Specialist-TCT/GMP

Loma Linda • Loma Linda, CA

2d • $87,755 - $118,040

About The Position

The Quality Assurance Specialist 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. The role monitors laboratory activities, reviews documentation, manages deviations and CAPAs, supports audits and inspections, and identifies 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.

Candidates must understand and embrace the mission, purpose, and identity of Loma Linda and its affiliated entities. Loma Linda University Health is a Seventh-day Adventist, faith- and values-based Christian institution.

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 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 communicate professionally in spoken and written English.
• Ability to use computer and software programs necessary for the position, such as Microsoft Office, document control, quality management, and laboratory information management systems, if applicable.
• 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; follow and enforce policies consistently; remain calm and courteous under pressure; collaborate; accept direction; think critically; and work independently with minimal supervision.
• Ability to perform basic math and statistical functions, manage multiple assignments, problem solve, 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.
• Must understand and embrace the mission, purpose, and identity of Loma Linda and its affiliated entities.

Responsibilities

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

What This Job Offers

• Job Type: Full-time