Job Description
Reporting directly to the Department Head – Chemistry 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.
Key Accountabilities:
Demonstrated experience conducting laboratory and full‑scale OOS investigations in compliance with GMP/ISO requirements.
Hands‑on experience with methods such as HPLC, GC, UV‑Vis, FTIR, titrations, and wet chemistry relevant to QC testing.
Proven ability to apply tools such as Fishbone, 5‑Whys, fault tree analysis, and trend analysis.
Including ALCOA+ expectations, documentation practices, and audit readiness.
Ability to critically evaluate chromatograms, calculations, system suitability, logbooks, and analyst practices.
Experience authoring clear, defensible investigation reports, defining CAPAs, and assessing effectiveness.
Ability to assess method performance, variability, and suitability during investigations.
Ability to work effectively with QC & QA teams, as well as communicating with other Departments.
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.
Strong scientific judgment to determine testing assignable cause versus true product failure.
Confidently defending OOS investigations during internal, customer, or regulatory audits.
Ability to manage multiple investigations simultaneously while meeting timelines.
Comfortable navigating laboratory systems and electronic quality records.
To Search, View & Apply for jobs on this site that accept applications from your location or country, tap here to make a Search: