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

MmtQOWxjOCtxc2k1SENPVDBsNGpBNVJkSUE9PQ==
  • 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

Similar Jobs

Ellis Medicine

Patient Care Technician A5 Days Job at Ellis Medicine

 ...Summary Patient Care Technician Do you have experience of working in a hospital and want to grow into a profession that makes a positive impact Do you thrive on diverse teams We are looking for a dynamic team-player who believes that collaboration communication... 

NavitasPartners

Sterile Processing Production Coordinator - 26-04924 Job at NavitasPartners

 ...Job Title: Sterile Processing Production Coordinator Location: Elmhurst, IL Duration: 13 Weeks Schedule: Night...  ...standards Troubleshoot workflow issues and implement process improvements Generate reports and provide updates to leadership as... 

Chick-fil-A

Front of House Team Member Job at Chick-fil-A

 ...We are looking for both full and part-time Hospitality Team Members to join the Chick-fil-A Lacey team and help us live out our vision of being the most caring company in Thurston County! Chick-fil-A Lacey is an opportunity for people of all ages and backgrounds, and no... 

New Wave Entertainment

Audio Editor (Entry Level) Job at New Wave Entertainment

 ...New Wave Entertainment is looking for an entry level Audio Editor to work in our Burbank facility. Candidates will be experienced in meeting deadlines and dealing with a high-pressure environment, typical of television marketing. This position works closely with onsite... 

Culver's

Restaurant General Manager Job at Culver's

 ...WE are looking for a General Manager to build help build, develop and lead! If you have a passion for leading teams and delighting guests in a fast-paced restaurant environment, then this job is for YOU! What we offer: Opportunities for Growth: We believe...