GMP Compliance Investigator - Equipment and Facilities - Marcus Center Cellular Cures

GMP Compliance Investigator
- Equipment and Facilities
- Marcus Center for Cellular Cures

Work Arrangement:
On-Site

Requisition Number: 272207

Regular or Temporary:
Regular

Location:

Durham, NC, US, 27710

Date:
Aug 5, 2026

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

Duke University’s Marcus Center for Cellular Cures has an
immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt Street Durham, NC. This position is currently on – site.

The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies and will have experience transferring processes to cGMP facilities for clinical or commercial manufacture.

They are expected to possess a high level of skill and experience with key bioprocess techniques and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Quality Assurance perspective for these processes.

Education/Training

Work generally requires a bachelor's degree in a biological Science.

Experience

Work requires six years of experience quality assurance or quality control related to clinical trials.

A Master's degree in a related field may be substituted for 2 years of required experience or an equivalent combination of relevant education and/or experience.

• Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation
• standards. As directed by the Associate Director, GMP Compliance, develop and edit Standard Operating Procedures (SOPs)
• related to the manufacturing of GMP products in the Robertson GMP Laboratory to ensure compliance with FDA and other
• applicable requirements. Edit batch records as needed. Initiate, author and complete deviations, CAPAs, memos and
• investigations related to manufacturing. Collaborate with QSU and manufacturing teams to investigate errors and complete
• deviations and CAPAs. Monitor Quality Agreements with sponsors to ensure timely notification of events as required per each specific agreement.

• As directed by the Associate Director, GMP Compliance, develop and edit Standard Operating Procedures (SOPs the Robertson
• GMP Laboratory to ensure compliance with FDA and other applicable requirements. Develop, author and complete change
• control request for SOP updates. Edit batch records as needed. Work closely with the Process Development team to establish
• SOPs for new manufacturing processes or optimization of existing ones.
• Initiate, author and complete deviations and investigations related to manufacturing SOP excursions. Collaborate with
• manufacturing and Quality to investigate errors and complete deviations and Corrective and…