Quality Auditor I or II
Core
Review GLP studies for completeness, compliance, and accuracy; provide regulatory guidance and lead quality event investigations to ensure safety in lab testing.
Role type
Quality Auditor (GLP/GMP)
Builds
Quality assurance for laboratory testing and sterilization services
Domain
Healthcare / Life Sciences / Laboratory Quality
Required skills
GLP/GMP/ISO regulatory knowledge, quality event investigation, CAPA management, protocol review, trend analysis, equipment qualification review, validation review, dashboard preparation, process improvement
Preferred skills
Microbiology or biological science degree, Master trainer certification, independent decision-making
Technologies
MasterControl, GLP, GMP, ISO
Responsibilities
Review GLP studies prior to release and final report mailing, perform quality event investigations and approvals, trend quality events, review and approve protocol detail sheets and amended reports, initiate and verify CAPA, prepare dashboards and quarterly management reviews, audit studies in-process, perform GHP audits
Seniority
Mid-level, hands-on IC