OOS Investigator - Eurofins BioPharma Product Testing, Inc.
Core
Leading and executing Out of Specification (OOS) and Out of Trend (OOT) investigations within an Analytical Quality Control laboratory to ensure data integrity and product quality.
Role type
Senior IC OOS Investigator (Analytical Chemistry)
Builds
Inspection-ready investigation reports, CAPAs, and regulatory compliance documentation for pharmaceutical and related products.
Domain
Pharmaceutical testing / Analytical Chemistry / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
OOS/OOT investigation execution, root cause analysis (RCA), GMP/GLP compliance, analytical techniques (HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry, microbiology), chromatogram evaluation, CAPA management, deviation management, method validation/verification, LIMS proficiency, technical writing, regulatory audit defense.
Preferred skills
Experience in contract laboratories, work with diverse formulations (solid/liquid dosage, creams, lotions), experience with NHPs, familiarity with Phase I vs Phase II investigation principles.
Technologies
HPLC, GC, UV-Vis, FTIR, eLIMS, Microsoft Office
Responsibilities
Conduct timely, scientifically sound OOS investigations; define and drive effective CAPAs; author clear, defensible investigation reports; collaborate with QC, QA, and clients; manage retesting and remeasurement; participate in audit preparations; review laboratory data and raw records.
Seniority
Mid-Senior, hands-on IC
