GMP QA Associate: Regulatory & SOP Specialist

University of Kansas Medical Center; United States; On-site; USD 34,000 - 50,000; Part time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Job summary

The University of Kansas Medical Center is seeking a Quality Assurance Associate to support QA and regulatory activities for the GMP facility within the Midwest Stem Cell Therapy Center. You will ensure compliance with FDA and other authorities, and assist in developing and maintaining SOPs and quality documents.

Responsibilities include documenting deviations, performing internal audits, managing training records, and coordinating with university areas to support mission and compliance with

Qualifications

• Four years of experience working in a regulated laboratory or manufacturing environment.
• Bachelor's degree in biology, life science or a related field preferred.
• Experience in GMP/GTP environments and FDA regulations is desirable.

Responsibilities

• Performs QA and regulatory responsibilities for GMP/GTP facility operations.
• Ensures compliance with FDA and other regulatory authorities.
• Develops, updates, and maintains SOPs and quality system documents.
• Maintains knowledge of applicable FDA regulations (cGMP; 21 CFR Parts 210, 211; 1271) and tissue regulations (21 CFR Part 1271).
• Manages QA aspects of clinical supply manufacturing, testing, packaging, storing and shipping operations.
• Assists with document management, batch record review, internal audits, and training records.

Skills

Detail oriented

Analytical thinking

Organization

Education

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

Job description

The University of Kansas Medical Center is seeking a Quality Assurance Associate to support QA and regulatory activities for the GMP facility within the Midwest Stem Cell Therapy Center. You will ensure compliance with FDA and other authorities, and assist in developing and maintaining SOPs and quality documents.

Responsibilities include documenting deviations, performing internal audits, managing training records, and coordinating with university areas to support mission and compliance with