QA Reviewer
Core
Review and approve laboratory testing data, reports, investigations, and calibration/maintenance documentation for release of finished products and raw materials in a GLP/GMP environment.
Role type
Senior QA Reviewer (Analytical)
Builds
Release testing of pharmaceutical/medical device products and raw materials
Domain
Pharmaceutical/Medical Device Quality Assurance
Required skills
HPLC troubleshooting, method validation, audit trail review, data integrity assessment, CAPA implementation, GLP/GMP compliance, equipment calibration, investigation of OOS results
Preferred skills
Project implementation of new specifications, internal/external audit participation, technical support for Analytical Team Leader
Technologies
Agilent HPLCs, Empower, Winsotax, LIMS
Responsibilities
Review and approve laboratory testing data and reports for release; Review and approve laboratory investigations; Troubleshoot and investigate out-of-specification results; Perform instrument calibration and maintenance; Support development of new methods and perform validation activities; Participate in internal and external audits and support implementation of CAPA actions.
Seniority
Senior, hands-on IC
