Quality Control Associate , GMP

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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.

The Cellular Therapy and GMP Manufacturing team is seeking a GMP Quality Control Associate I to help advance the development and delivery of innovative cellular therapies for clinical and commercial applications. In this role, you will support analytical development, product release testing, environmental monitoring, and quality systems activities within a GMP-regulated environment. Your work will directly contribute to ensuring that cellular therapy products meet the highest standards of quality, safety, and regulatory compliance while supporting groundbreaking therapies for patients.

This is an excellent opportunity for a quality-focused laboratory professional who enjoys working in a fast-paced, collaborative environment and wants to contribute to the advancement of novel cell and gene therapies.

Minimum Requirements:

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific field.
• Two years of experience in a laboratory, manufacturing, quality, or other regulated environment.

Essential Tasks

• Perform pharmaceutical development and successful GMP release including Analytical development, assisting the QC Manager and Product Development team in development of specific release and characterization methods
• Aid in qualifying methods for product release and complete comprehensive characterization of clinical lots.
• Complete GMP testing in line with ICH and regulatory guidance.
• Lead qualification testing of cellular therapy products including tech transfer and associated testing under GMP conditions.
• Execute and document development and GMP activities in compliance with regulatory requirements.
• Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
• Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilize the data in appropriate decision making; summarize data, present results, and propose next steps to advance development.
• Write and reviews development reports; writes protocols for use in GMP facility and SOPs for GMP production and presents data to project teams and larger settings.
• Write and review QC deviations, non-conformances, CAPAs, out of specifications, complaints, and all associated required reporting.
• Ship and prepare samples for outside vendors for quality control testing. Engage external vendors for coordination of quality control testing.
• Operate and maintain equipment utilized in characterization and qualification testing.
• Perform routine environmental monitoring of the…