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