SOKOL GxP Services

Deviation Investigator – QC, GMP

SOKOL GxP Services

contract

Posted on:

Location Type: Hybrid

Location: Devens • Massachusetts • United States

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Salary

💰 $44 - $53 per hour

About the role

  • 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

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
root cause analysisCAPA managementdeviation investigationsdata trendingstatistical analysiscell culturerecovery processespurification processesGMP experienceQRM principles
Soft Skills
collaborationpresentation skillsdecision-makingcontinuous improvementoperational excellence
Certifications
Bachelor’s degree in BiologyBachelor’s degree in BiochemistryBachelor’s degree in Chemical Engineering