Summary from listing
The QA Systems Specialist will support daily quality assurance activities at Guerbet’s Raleigh site, ensuring compliance with cGMP, FDA, international regulatory requirements, and company quality systems. The role oversees change controls, quality-system metrics, documentation reviews, risk communication, audit readiness, and collaboration with manufacturing, quality control, supply chain, engineering, and regulatory affairs teams. Candidates need a bachelor’s degree in a relevant scientific discipline, at least five years of experience in a pharmaceutical, biotechnology, or cGMP-regulated industry, and experience with quality systems, regulatory inspections, audits, and change controls.
