OOS Investigator - Eurofins BioPharma Product Testing, Inc.

Please note that relocation to Mississauga, ON is expected in mid-2026.

Reporting directly to the Director/BUMA, Dept. of Chemistry, the OOS investigator will work within BPT and working closely with QA Dept, the OOS Investigator is responsible for leading and executing Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations within the Analytical Quality Control laboratory. This role ensures that laboratory investigations are conducted in a scientifically sound, timely, and compliant manner in accordance with GMP/GLP and internal quality systems. The OOS Investigator evaluates analytical data, identifies root causes, determines product impact, and supports the implementation of effective corrective and preventive actions (CAPAs) to maintain data integrity and product quality.

A suitable candidate must be energetic, well-organized, self-disciplined and flexible. Efficient communication is a mandatory requirement to interact within the Team and with Management, in a fast-paced environment, sometimes under pressure, while remaining proactive, resourceful, and efficient. A high level of professionalism and confidentiality is crucial to this role. Additional roles and duties may be assigned as needed.

 The OOS investigator must:

• Strong knowledge of OOS/OOT investigations
  Demonstrated experience conducting laboratory and full‑scale OOS investigations in compliance with GMP/ISO requirements.
• Thorough understanding of analytical techniques
  Hands‑on experience with methods such as HPLC, GC, UV‑Vis, FTIR, titrations, wet chemistry and Microbiology skills relevant to QC testing.
• Expertise in root cause analysis (RCA)
  Proven ability to apply tools such as Fishbone, 5‑Whys, fault tree analysis, and trend analysis.
• Solid understanding of GMP, GLP, and data integrity principles
  Including ALCOA+ expectations, documentation practices, and audit readiness.
• Experience reviewing laboratory data and raw records
  Ability to critically evaluate chromatograms, calculations, system suitability, logbooks, and analyst practices.
• Strong deviation and CAPA management skills
  Experience authoring clear, defensible investigation reports, defining CAPAs, and assessing effectiveness.
• Knowledge of method validation and verification principles
  Ability to assess method performance, variability, and suitability during investigations.
• Cross‑functional collaboration skills
  Ability to work effectively with QC & QA teams, as well as communicating with other Departments.
• Excellent technical writing skills
  Capable of producing clear, concise, and inspection‑ready investigation reports, as well as writing eloquent professional emails to the Clients delivering the OOS results/reports.
• Ability to distinguish laboratory error vs. process‑related issues
  Strong scientific judgment to determine testing assignable cause versus true product failure.
• Experience supporting audits and inspections
  Confidently defending OOS investigations during internal, customer, or regulatory audits.
• Strong organizational and time‑management skills
  Ability to manage multiple investigations simultaneously while meeting timelines.
• Proficiency with LIMS and electronic documentation systems
  Comfortable navigating laboratory systems and electronic quality records.
• Conduct timely, scientifically sound OOS Investigations.
• Ensure full compliance with Phase I vs Phase II Investigation principles according to Internal SOPs as well against the FDA guidance for Investigations.
• Manage and schedule Retesting and Re measurement in a controlled manner
• Deliver and keep high-quality, Inspection ready OOS documentation.
• Drive effective CAPAs and prevent recurrence.
• Collaborate effectively with Clients, within the Team and with Management.
• Identify and Trend OOS / OOT signals proactively.
• Maintain Inspection Readiness and Regulatory Awareness.
• Ensure that work is performed in compliance with good manufacturing practices (GMP), standard operating procedures (SOPs);
• Participate in typing and reviewing of Methods/Workbook templates/SOPs in electronic format in eLIMS;
• Participation in meetings and routine Lab Support Operations, contribution to Lab Audit preparations in assistance with tasks assigned by QA and QC Management.
• Work productively and cooperatively with other departments and supervisors to attain company objectives.
• Follow SOPs on investigations and CAPAs.
• Ensure all lab personnel are working safely and in adherence to company health and safety policy and procedures.