GMP QA Specialist - Cell Therapy & Lab Quality

Loma Linda University Health; Loma Linda (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Loma Linda University Health is seeking a Quality Assurance Specialist-TCT/GMP to oversee quality operations in the TCT/GMP Laboratory. The role ensures compliance with regulations, FACT accreditation, and institutional policies, while developing and maintaining quality systems and supporting audits.

The candidate will review documentation, manage deviations and CAPAs, monitor activities, and contribute to continuous improvement to ensure product quality and safety in cell therapy manufacturing

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• Three years of QA/QC or GMP-regulated experience required.
• Knowledge of FDA/FACT/IRB/IND/IDE standards preferred.

Responsibilities

• Provide quality oversight for TCT/GMP Laboratory operations.
• Lead design and implementation of the lab's quality management systems.
• Monitor activities, review documentation, and manage deviations and CAPAs.
• Support audits and inspections and drive continuous improvement.

Skills

GMP compliance

QMS awareness

Documentation control

Team collaboration

Education

Bachelor's degree in Life Sciences

Tools

LIMS

Microsoft Office

Job description

Loma Linda University Health is seeking a Quality Assurance Specialist-TCT/GMP to oversee quality operations in the TCT/GMP Laboratory. The role ensures compliance with regulations, FACT accreditation, and institutional policies, while developing and maintaining quality systems and supporting audits.

The candidate will review documentation, manage deviations and CAPAs, monitor activities, and contribute to continuous improvement to ensure product quality and safety in cell therapy manufacturing