OOS Investigator - Pharmaceutical Product Testing

About the role

Eurofins BioPharma Product Testing is hiring an OOS Investigator in its Analytical Quality Control laboratory, reporting to the Director/BUMA, Department of Chemistry and working closely with the QA department. The role leads and executes Out of Specification (OOS) and Out of Trend (OOT) investigations in a scientifically sound, timely and compliant way, in line with GMP/GLP and internal quality systems. Relocation to Mississauga, ON is expected in mid-2026.

Key responsibilities

• Conduct OOS and OOT investigations in compliance with GMP/ISO requirements and Phase I vs Phase II investigation principles, including FDA guidance.
• Evaluate analytical data, identify root causes, determine product impact and support CAPAs to protect data integrity and product quality.
• Manage retesting and re-measurement, and deliver inspection-ready documentation.
• Identify and trend OOS/OOT signals proactively and maintain inspection readiness.
• Review laboratory data and raw records, including chromatograms, calculations, system suitability, logbooks and analyst practices.
• Author investigation reports and CAPAs, and defend investigations during internal, customer or regulatory audits.
• Take part in typing and reviewing methods, workbooks and SOPs in eLIMS, and help prepare for lab audits.

Required profile

• B.Sc. or higher in Chemistry, Biochemistry or a related field, or a diploma in a related field.
• At least 5 years in a QC laboratory with different analytical instruments, and 2-5 years leading investigations.
• Solid understanding of analytical chemistry, wet chemistry and instrumentation, and of GMP/GDP/GLP.
• Experience with pharmaceutical products and formulations (solid and liquid dosage forms, creams, lotions, ointments) is an asset; contract laboratory experience is an asset.
• Working independently, strong computer and organizational skills, and clear verbal and written communication.

Required skills

• Root cause analysis (Fishbone, 5-Whys, fault tree, trend analysis)
• HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry and microbiology
• LIMS and electronic documentation systems
• Microsoft Office

What we offer

• Full-time position with health and dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays and paid time off.
• Eligible for overtime pay; no direct reports and no significant managerial responsibilities.