Deviation Investigator - QC / GMP Job at SOKOL GxP Services, Devens, MA

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  • SOKOL GxP Services
  • Devens, MA

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

Job Tags

Hourly pay, Contract work, Monday to Friday

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