Part-Time GMP QA Associate — Regulatory & Quality

University of Kansas Medical Center; Kansas City (KS); Hybrid; USD 34,000 - 50,000; Part time

Job summary

University of Kansas Medical Center seeks a Quality Assurance Associate to oversee QA and regulatory activities for the GMP/GTP facility at the Midwest Stem Cell Therapy Center. You will ensure compliance with FDA regulations and maintain quality systems, SOPs, and training records.

The role involves document control, batch record review, internal audits, and investigation of deviations, CAPAs, and other quality events, with collaboration across university departments.

Qualifications

• Four (4) years of experience working in a regulated laboratory or manufacturing environment, such as GMP, GTP, CLIA, CAP, FDA-regulated, or equivalent settings.
• Education may substitute for experience on a year-for-year basis.
• Bachelor's degree in biology, life science or related field.
• Experience in a GMP environment for the manufacture of cellular therapy products.
• Experience and working knowledge of FDA regulations, especially cGMP; 21 CFR Parts 210 and 211; and cGTP; 21 CFR Part 1271.

Responsibilities

• Performs all QA and regulatory responsibilities for the GMP and GTP facility within the Midwest Stem Cell Therapy Center at KUMC.
• Maintain compliance with FDA regulations and other regulatory authorities.
• Develop, update, and modify SOPs and other quality system documents as protocols change.
• Document management and batch record review.
• Perform internal audit/review systems and investigate deviations, nonconformances, CAPAs, and other quality events.
• Maintain logbooks and ongoing GMP documentation; assist with training and training records.
• Coordinate with other University areas to support the university mission.

Skills

Detail oriented

Analytical thinking

Organization

Education

Bachelor's degree in biology, life science or related field

Job description

University of Kansas Medical Center seeks a Quality Assurance Associate to oversee QA and regulatory activities for the GMP/GTP facility at the Midwest Stem Cell Therapy Center. You will ensure compliance with FDA regulations and maintain quality systems, SOPs, and training records.

The role involves document control, batch record review, internal audits, and investigation of deviations, CAPAs, and other quality events, with collaboration across university departments.