OOS Investigator - BioPharma Product Testing, Inc.

• Full-time
• Compensation: CAD 55,000 - CAD 55,000 - yearly

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2025, Eurofins generated total revenues of EUR 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years.

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…