Deviation Investigator - QC / GMP

Job description

SOKOL GxP Services is seeking a Deviation Investigator to support Quality Control operations in a GMP-regulated environment. This role focuses on deviation management, root cause investigations, and CAPA execution within a GMP-regulated environment. This is a hands-on role working cross-functionally with QC, Manufacturing, and Quality teams to ensure timely and compliant investigation closure. Key Responsibilities: - Lead and manage deviations, investigations, impact assessments, and CAPAs - Perform root cause analysis (RCA) using formal investigation tools - Drive timely closure of investigations and CAPAs - Investigate QC events including OOS (Out-of-Specification) and OOT (Out-of-Trend) results - Collaborate cross-functionally with QC, Manufacturing, and Quality teams - Present findings to stakeholders and site leadership - Apply Quality Risk Management (QRM) principles for decision-making - Support continuous improvement and operational excellence initiatives Requirements: Required Qualifications: - Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, or related field - 2–4+ years of GMP experience Hands-on experience with: - Deviation investigations - Root Cause A...