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