Gmp, Quality Assurance Associate Ii

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 Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate II to join our team. In this role, you will help ensure that the products, materials, and processes used in Duke's GMP programs meet the highest standards of quality and compliance. You will play a key part in supporting the Marcus Center for Cellular Cures (MC3) GMP Facility – an innovative environment where your work directly impacts clinical research and patient‑focused manufacturing.

• Support and evolve quality systems, including investigations and supply qualification systems.
• Build tools to analyze and assess quality metrics; guide teams on GMP expectations.
• Shape continuous improvement efforts and support inspections, giving you a front‑row seat to the full lifecycle of GMP operations.
• Represent QA in cross‑functional settings and provide quality guidance in project meetings.
• Write, revise, and review SOPs to ensure compliant operations.
• Track and trend quality metrics to identify areas of concern.
• Assist with inspections and manage quality‑related matters during audits.
• Review and guide deviations and investigations, collaborating with end users to resolve issues.
• Train staff on GMP principles, investigations, and root cause analysis.
• Review product records for release of clinical trial materials and components when required.
• Participate in multiple programs across various development phases.
• Conduct environmental monitoring and assist with data analysis when required.
• Conduct audits under the supervision of the Lead Auditor and generate audit reports.

This position is onsite. Work is performed on‑site or at a designated assignment location.

• Bachelor's degree required.
• Minimum 5 years of experience in a GMP or similar regulated environment.
• Experience training users in implementing Quality Systems.
• Prior laboratory experience preferred.
• Experience preparing for external audits and/or site visits.
• Experience reviewing raw materials, supplies, and manufactured products for acceptability.
• Master's or Ph.D. may substitute for experience.
• Or any equivalent combination of relevant education and/or experience.

• Bachelor's degree in life sciences or a related field.
• Experience serving as final QA signature for release of raw materials or finished products.
• Experience representing QA in cross‑functional settings and reporting back to the department.
• Experience with validation and/or technical quality engineering support of manufacturing operations (required).
• Master's or Ph.D. may substitute for experience except for validation/technical quality engineering requirements.

• Proficient knowledge of GLP, GMP, and/or GTP.
• Strong leadership, organizational, and time‑management skills.
• Ability to train staff effectively.
• High attention to detail in document review.
• Strong interpersonal, verbal, and written communication skills.
• Ability to work independently or collaboratively in a fast‑paced environment.
• Adaptability to shift priorities.
• Problem‑solving skills and a sense of urgency in completing tasks.

Anticipated Pay Range:
Annual base salary range USD $86,714.00 to USD $.

Benefits include comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy‑related conditions), sexual orientation, or military status.

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS; phone: 919‑668‑1267).