GMP Compliance Investigator: Equipment & Facilities

Duke University; Durham (NC); In loco; USD 67.919 - 102.898; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Retirement benefits

Tuition assistance

Paid time off

Descrizione del lavoro

Duke University’s Marcus Center for Cellular Cures seeks a GMP Compliance Investigator – Equipment and Facilities to ensure FDA and FACT-compliant manufacturing lab operations in Durham, NC. The role focuses on QA/regulatory activities for cGMP programs, deviations, CAPAs, and SOPs with strong documentation and collaboration with QA and Process Development teams.

Ideal candidates will have a bachelor's in a biological science and at least six years in QA/QC related to clinical trials, with a

Competenze

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

Mansioni

• Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation.
• Edit SOPs and change controls; review deviations, CAPAs and batch records.
• Coordinate with QA, Process Development, and manufacturing teams to resolve quality issues and support product release.

Conoscenze

Quality Assurance

GMP Compliance

Documentation

Formazione

Bachelor's degree in Biological Science

Descrizione del lavoro

Duke University’s Marcus Center for Cellular Cures seeks a GMP Compliance Investigator – Equipment and Facilities to ensure FDA and FACT-compliant manufacturing lab operations in Durham, NC. The role focuses on QA/regulatory activities for cGMP programs, deviations, CAPAs, and SOPs with strong documentation and collaboration with QA and Process Development teams.

Ideal candidates will have a bachelor's in a biological science and at least six years in QA/QC related to clinical trials, with a