OOS Investigator - Eurofins BioPharma Product Testing, Inc.

Eurofins•Toronto, ON

40d•CA$55,000 - CA$55,000•Onsite

About The Position

Eurofins BioPharma Product Testing, Inc. is seeking an OOS Investigator to join their Analytical Quality Control laboratory. This role is responsible for leading and executing Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations. The investigator will ensure these investigations are conducted in a scientifically sound, timely, and compliant manner, adhering to GMP/GLP and internal quality systems. Key responsibilities include evaluating analytical data, identifying root causes, determining product impact, and supporting the implementation of corrective and preventive actions (CAPAs) to maintain data integrity and product quality. The ideal candidate should be energetic, well-organized, self-disciplined, flexible, and possess strong communication skills for interacting with the team, management, and clients, sometimes under pressure. A high level of professionalism and confidentiality is essential. Additional roles and duties may be assigned as needed. Relocation to Mississauga, ON is expected in mid-2026.

Requirements

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.
B.Sc. or higher degree in Chemistry, Biochemistry, or diploma in related field;
A solid background and understanding of Analytical Chemistry, variety of Wet Chemistry and Instrumentation techniques and GMP/GDP/GLP requirements is mandatory.
Computer proficiency- Microsoft Office, eLIMS, etc..
At least 5 years working in the QC Lab - with different analytical instrumentation.
2-5 years of experience in leading investigations.
Ability to perform preliminary data review as part of investigation.
Work competently without direct supervision while applying technical laboratory skills.
Strong computer, organizational skills.
Clear verbal and written communication skills.
Skilled in data/report generation, retrieval and interpretation of routine analysis.
2-5+ years working with applied chemistry techniques.

Nice To Haves

Any certificate or course related to Investigations or QA/QC related courses are an asset.
Experience working in contract Laboratory considered an asset.
Experience working with pharmaceutical products, NHPs, and variety of formulations viz solid dosage, liquid dosage forms along with creams, lotions, ointments and other challenging matrixes is an asset
Experience working with pharmaceutical clients and products.
Experience working in a contract laboratory considered an asset.

Responsibilities

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.