OOS Investigator Eurofins Cosmetics & Personal Care, Inc.

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:

• Strong knowledge of OOS/OOT investigations
  Demonstrated experience conducting laboratory and fullscale OOS investigations in compliance with GMP/ISO requirements.
• Thorough understanding of analytical techniques
  Handson experience with methods such as HPLC GC UVVis FTIR titrations and wet chemistry relevant to QC testing.
• Expertise in root cause analysis (RCA)
  Proven ability to apply tools such as Fishbone 5Whys 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.
• Crossfunctional 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 inspectionready investigation reports as well as writing eloquent professional emails to the Clients delivering the OOS results/reports.
• Ability to distinguish laboratory error vs. processrelated 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 timemanagement 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;
• 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.

Qualifications :

• . or . 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..;
• Any certificate or course related to Investigations or QA/QC related courses are an asset.
• 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;
• 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.

 Soft Skills

• Must speak and write English fluently;
• Must possess excellent communication skills both written and verbal in order to present responses to clients and auditors prepare reports and maintain a high level of information flow with internal and external clients;
• Excellent organizational skills;
• High level of accuracy and strong attention to detail;
• Ability to work independently while supervising a collaborative team-based matrixed department;
• Ability to multitask and remain calm under pressure;
• High level of professionalism maturity good judgment and discretion when dealing in confidential matters;
• Must be mature proactive self-disciplined and able to demonstrate a high level of productivity and self-motivation;
• Demonstrated excellent departmental work performance and attendance record.

WORKING CONDITIONS

This position will be working in office and lab environments. Moderate level of activity and some light lifting requirements to fulfill any required duties. Evening or weekend work may occasionally be required.

Additional Information :

At Eurofins we offer excellent full-time benefits including health & dental coverage life and disability insurance RRSP with 3% company match paid holidays paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process or those needing job postings in an alternative format may e-mail a request via the website at .

As a Eurofins employee you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins please explore our website at 

We thank all applicants within commuting distance of GTA Ontario for showing an interest in this position. Only those selected for an interview will be contacted.

This posting is supported by AI technology to assist in screening candidates and resumes. 

This posting is for a current vacancy and the successful candidate will start as soon as possible.

Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organizations compensation and may represent estimated ranges provided by third-party job boards. The organization offers competitive wages and a comprehensive total rewards package which will be discussed during the interview process.

NO AGENCIES CALLS OR EMAILS PLEASE

Remote Work :

No

Employment Type :

Full-time