GMP Quality Control Associate I (Cellular Therapies)

Duke University; Durham (NC); Presencial; USD 68.000 - 103.000; Jornada completa

Descripción de la vacante

Duke University is seeking a GMP Quality Control Associate I to support analytical development, product release testing, environmental monitoring, and quality systems within a GMP-regulated environment. Your work will help ensure cellular therapy products meet high standards of quality and regulatory compliance while supporting innovative therapies.

This onsite role requires a science degree and relevant regulated-environment experience, with responsibilities spanning development, testing,

Formación

• 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.
• Strong analytical problem solving and communication skills.

Responsabilidades

• Perform pharmaceutical development and GMP release testing including analytical development and characterization methods.
• Lead qualification testing of cellular therapy products including tech transfer and GMP conditions.
• Write and review development reports and QC deviations, CAPAs, out-of-specifications, and related documentation.
• Collaborate with manufacturing, process development, quality assurance, and external testing partners.

Descripción del empleo

Duke University is seeking a GMP Quality Control Associate I to support analytical development, product release testing, environmental monitoring, and quality systems within a GMP-regulated environment. Your work will help ensure cellular therapy products meet high standards of quality and regulatory compliance while supporting innovative therapies.

This onsite role requires a science degree and relevant regulated-environment experience, with responsibilities spanning development, testing,