GMP Quality Control Associate II

1w1 week ago

Duke University

Durham, US · Full-time · $86,714 – $140,129

About this role

The Office of Regulatory Affairs & Quality (ORAQ) at Duke University School of Medicine seeks a GMP Quality Control Associate II. Support the development, qualification, and execution of analytical methods required for the release of cellular therapy products used in clinical trials and commercial operations. Perform specialized GMP testing, environmental monitoring, and quality control activities with minimal oversight.

Ensure products and facilities remain compliant with applicable regulatory requirements through independent execution of quality control activities. Work closely with Manufacturing, Product Development, and external partners to produce high-quality clinical and commercial cellular therapy products. Serve as a technical resource to manufacturing operations and junior staff.

Join an integral role on a collaborative Quality Control team within a world-class academic medical center. Contribute expertise to investigations, process improvements, and regulatory readiness activities. Embrace interdisciplinary collaboration in an inclusive community of outstanding learners, investigators, clinicians, and staff.

Operate in a GMP cleanroom environment onsite at a designated location. Demonstrate leadership by mentoring junior staff and representing Quality Control in cross-functional efforts. Accelerate translation of scientific discoveries to improve human health locally and globally.

Requirements

Bachelor’s degree
5 years of experience in a GxMP or similarly regulated environment
Prior laboratory experience in product testing
Experience training Quality personnel
Experience preparing for and supporting external audits and/or site visits
Experience reviewing raw materials, analytical methods, test results, supplies, and manufactured products for acceptability
Proficient working knowledge of GLP, GMP, and/or GTP

Responsibilities

Support the development, qualification, and execution of analytical methods required for the release of cellular therapy products
Perform specialized GMP testing, environmental monitoring, and quality control activities
Ensure products and facilities remain compliant with applicable regulatory requirements
Work closely with Manufacturing, Product Development, and external partners
Serve as a technical resource to manufacturing operations and junior staff
Contribute to investigations, process improvements, and regulatory readiness activities