GMP Quality Control Associate I – Cell Therapy

Duke Clinical Research Institute; Durham (NC); On-site; USD 68,000 - 103,000; Full time

Job summary

Duke University is seeking a GMP Quality Control Associate I in Durham, NC, to support cellular therapy programs in a fast-paced GMP environment. You will perform analytical development, GMP release testing, environmental monitoring, and contribute to quality systems under supervision to ensure product quality and regulatory compliance.

The role involves collaboration with QA, manufacturing and development teams, data interpretation, documentation of results, and potential involvement in audits;

Qualifications

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering or related field.
• Two years of experience in a laboratory, manufacturing, quality, or other regulated environment.
• Strong analytical problem-solving skills and ability to work independently.
• Excellent written and verbal communication skills.

Responsibilities

• Perform pharmaceutical development and GMP release testing including Analytical development.
• Assist the QC Manager and Product Development in method development and validation.
• Lead GMP testing and data analysis for clinical lots.
• Coordinate with external vendors for quality control testing.
• Maintain equipment and perform routine environmental monitoring.

Skills

Analytical methods

GMP experience

Independent work

Problem solving

Communication

Education

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering

Job description

Duke University is seeking a GMP Quality Control Associate I in Durham, NC, to support cellular therapy programs in a fast-paced GMP environment. You will perform analytical development, GMP release testing, environmental monitoring, and contribute to quality systems under supervision to ensure product quality and regulatory compliance.

The role involves collaboration with QA, manufacturing and development teams, data interpretation, documentation of results, and potential involvement in audits;