GMP, Quality Control Associate II

Overview

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 six thousand two hundred 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.

The Office of Regulatory Affairs & Quality (ORAQ) is seeking a GMP, Quality Control Associate II to join our team. In this role, you will support the development, qualification, and execution of analytical methods required for the release of cellular therapy products used in clinical trials and commercial operations. With minimal oversight and often independently, you will perform specialized GMP testing, environmental monitoring, and quality control activities to ensure products and facilities remain compliant with applicable regulatory requirements.

As an integral member of a collaborative Quality Control team, you will work closely with Manufacturing, Product Development, and external partners to ensure the production of high quality clinical and commercial cellular therapy products. You will also serve as a technical resource to manufacturing operations and junior staff, contributing your expertise to investigations, process improvements, and regulatory readiness activities.

• Bachelor's degree
• 5 years of experience in a GxMP or similarly regulated environment
• (A Master's or PhD may substitute for required experience)
• 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

• Experience serving as final signature authority for QC release of test results, raw materials, and finished products
• Experience representing the Quality Control department in cross functional meetings and reporting outcomes to QC leadership
• Experience leading laboratory investigations, root cause analysis, and CAPA development

• Proficient working knowledge of GLP, GMP, and/or GTP
• Strong organizational and time management skills with the ability to manage multiple priorities
• Demonstrated leadership abilities and experience mentoring or training junior staff
• Strong attention to detail, particularly in documentation and data review
• Excellent verbal, written, and interpersonal communication skills
• Strong problem solving skills and adaptability to changing priorities
• Ability to work independently and collaboratively in a team environment
• Ability to work effectively in a GMP cleanroom environment

This position is Onsite. The work is performed on-site or at a designated assignment location.

With minimal oversight and/or independently, you will:

• Perform pharmaceutical development and GMP release testing, including analytical method development in collaboration with the QC Manager and Product Development team
• Qualify analytical methods for product release and perform comprehensive characterization of clinical and commercial lots
• Execute GMP testing in alignment with ICH guidelines and regulatory requirements
• Lead qualification testing and technical transfer activities for cellular therapy products under GMP conditions
• Document and execute development and GMP activities in full compliance with regulatory and quality standards
• Collaborate with development and manufacturing teams to assess how process changes impact product quality
• Compile, analyze, interpret, and summarize data; present results and recommend next steps to advance development programs
• Author and review development reports, protocols, SOPs, and GMP documentation; present data to project teams and broader audiences
• Write, coordinate, and review deviations, nonconformances, OOS events, CAPAs, complaints, and required reports
• Prepare and ship samples to external vendors and coordinate outsourced quality control testing
• Operate, maintain, and qualify equipment used in characterization and qualification testing
• Perform routine environmental monitoring to ensure the GMP facility remains in a state of microbial control
• Serve as a key QC resource in the cleanroom and mentor junior staff in GMP best…