OOS Investigator

Responsibilities

• Lead and execute Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations
• Conduct laboratory investigations in compliance with GMP/GLP and internal quality systems
• Evaluate analytical data, identify root causes, and determine product impact
• Support the implementation of effective corrective and preventive actions (CAPAs)
• Manage and schedule Retesting and Re-measurement in a controlled manner
• Identify and trend OOS/OOT signals proactively
• Maintain inspection readiness and regulatory awareness
• Collaborate with QC, QA, and other departments to ensure compliance and safety

Requirements

• B.Sc. or higher degree in Chemistry, Biochemistry, or related field
• At least 5 years of experience working in a QC Lab with analytical instrumentation
• 2-5 years of experience leading investigations
• Strong knowledge of OOS/OOT investigations and GMP/GLP/GDP requirements
• Hands-on experience with HPLC, GC, UV-Vis, FTIR, and wet chemistry
• Expertise in root cause analysis (RCA) tools like Fishbone and 5-Whys
• Proficiency with LIMS and Microsoft Office
• Excellent technical writing skills for investigation reports

Preferred Qualifications

• Experience working in a contract laboratory environment
• Experience with pharmaceutical products, NHPs, and various dosage forms (solid, liquid, creams)
• Certification or coursework related to Investigations or QA/QC

Benefits

• Health and dental coverage
• Life and disability insurance
• RRSP with 3% company match
• Paid holidays and paid time off

About the Company

Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries to ensure product safety, authenticity, and quality.