Deviation Investigator - QC / GMP

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 Analysis (RCA) tools CAPA management Experience in QC environment Strong understanding of: cGMP regulations SOP-driven environments Preferred Experience Experience with

OOS / OOT

investigations Exposure to cell culture, recovery, or purification processes Familiarity with data trending / basic statistical analysis Experience working in biopharmaceutical manufacturing environments Benefits Competitive hourly rate: $43.50 - 53.20/hr (W-2 only, no C2C) Hybrid position - 50% onsite required

Working Hours:

Monday - Friday, regular business hours 6-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits