About The Position

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.

Requirements

  • A B.Sc. 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 3-5 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

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 Cosmetic Products, such as creams, lotions, ointments and other challenging matrixes is an asset

Responsibilities

  • Conduct timely, scientifically sound OOS Investigations
  • Ensure full compliance with Phase I vs Phase II Investigation principles according to Internal SOPs
  • 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

Benefits

  • Competitive wages
  • Comprehensive total rewards package
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