Coordinator–TCT/GMP Quality Assurance

Loma Linda • Loma Linda, CA

7h • $55 - $74 • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Life Sciences or an equivalent field of study required.
• 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.
• Able to 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.
• Able to analyze and interpret complex information.
• Able to prioritize work and resources.
• Able to define problems and solutions.
• Able to make recommendations.
• Able to manage time effectively.
• Able to relate and communicate positively, effectively, and professionally with others.
• Able to be assertive and consistent in following and/or enforcing policies.
• Able to work calmly and respond courteously when under pressure.
• Able to collaborate.
• Able to accept direction.
• Able to think critically.
• Able to work independently with minimal supervision.
• Able to perform basic math functions and statistical functions.
• Able to manage multiple assignments effectively.
• Able to problem solve.
• Able to recall information with accuracy.
• Able to pay close attention to detail.
• Able to distinguish colors as necessary.
• Able to hear sufficiently.
• Able to see adequately to read computer screens, and written documents necessary to the position.

Nice To Haves

• 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.
• California Clinical Laboratory Scientist License preferred.

Responsibilities

• Oversees quality assurance and regulatory compliance activities for LLUH TCT/GMP Laboratory.
• Ensures adherence to FDA, FACT, IRB, and other applicable standards.
• Manages the Quality Management System (QMS), including SOPs, audits, CAPA programs, inspection readiness, regulatory submissions, staff training, and accreditation support.
• Collaborates with laboratory leadership, investigators, and institutional stakeholders to support compliant cellular therapy manufacturing operations.
• Leads process improvement initiatives.
• Monitors supplier and material quality.
• Prepares compliance reports.
• Provides operational support for TCT/GMP production and quality control activities as qualified.
• Performs other duties as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level