GMP Quality Assurance Associate — Cell Therapy

The University of Kansas Health System; Kansas City (MO); On-site; USD 34,000 - 50,000; Part time

Job summary

The University of Kansas Health System's Midwest Stem Cell Therapy Center is seeking a Quality Assurance Associate to perform QA and regulatory work for the GMP facility, ensuring FDA compliance and maintaining SOPs, forms and quality systems. You will assist with documentation, audits, and regulatory activities in a part-time role at the Kansas City campus.

Under the Associate Director, you will support batch record review, deviations, CAPAs, training, and cross-functional collaboration to

Qualifications

• Four (4) years of experience in a regulated laboratory or manufacturing environment.
• Bachelor’s degree in biology, life science or a related field.
• Experience with FDA regulations and GMP/GTP environments.

Responsibilities

• Performs QA and regulatory responsibilities for GMP/GTP facility operations.
• Maintain compliance with FDA regulations and other authorities.
• Develop, review, update SOPs and quality system documents.
• Manage document control, batch records review, and training records.
• Support internal audits, deviations, CAPAs, and quality events.
• Ensure proper equipment and GMP environment maintenance.
• Coordinate with other university areas to support institutional mission.

Job description

The University of Kansas Health System's Midwest Stem Cell Therapy Center is seeking a Quality Assurance Associate to perform QA and regulatory work for the GMP facility, ensuring FDA compliance and maintaining SOPs, forms and quality systems. You will assist with documentation, audits, and regulatory activities in a part-time role at the Kansas City campus.

Under the Associate Director, you will support batch record review, deviations, CAPAs, training, and cross-functional collaboration to