GMP Compliance Investigator – Equipment & Facilities

Duke University; Durham (NC); In loco; USD 68.000 - 103.000; Tempo pieno

Descrizione del lavoro

The Marcus Center for Cellular Cures at Duke University is seeking a GMP Compliance Investigator – Equipment and Facilities for its on-site Durham lab. The role focuses on ensuring FDA and FACT compliant operations in the Robertson GMP Laboratory, with emphasis on equipment and facilities integrity.

Responsibilities include developing SOPs, handling deviations and CAPAs, coordinating with QA and Process Development, and supporting batch release activities in a regulated bioprocess environment.

Competenze

• Bachelor's degree in Biological Science required.
• Six years of experience in QA or QC related to clinical trials required.
• Master's degree may substitute for 2 years of experience or equivalent combination of education/experience.

Mansioni

• Enable compliance of the GMP laboratory with FDA and FACT standards.
• Develop and edit SOPs for GMP manufacturing and QC.
• Initiate, author and close deviations, CAPAs, and investigations.
• Collaborate with QA and manufacturing to support batch release and audits.

Conoscenze

Quality Assurance

cGMP Knowledge

Technical writing

Auditing

Formazione

Bachelor's degree in Biological Science

Master's degree may substitute for 2 years experience

Strumenti

Electronic QMS software

Descrizione del lavoro

The Marcus Center for Cellular Cures at Duke University is seeking a GMP Compliance Investigator – Equipment and Facilities for its on-site Durham lab. The role focuses on ensuring FDA and FACT compliant operations in the Robertson GMP Laboratory, with emphasis on equipment and facilities integrity.

Responsibilities include developing SOPs, handling deviations and CAPAs, coordinating with QA and Process Development, and supporting batch release activities in a regulated bioprocess environment.