Deviation Investigator - QC / GMP
SOKOL GxP Services•Devens, MA
•$44 - $53•Hybrid
About The Position
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.
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
Nice To Haves
- 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
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
Benefits
- Health insurance
- Holiday pay
- 401(k) program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Career Level
Mid Level
