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 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

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