
Analytical Laboratory Investigator - Eurofins Experchem Laboratories, Inc
- Toronto, ON
- Permanent
- Full-time
- OOS Investigations: Lead OOS investigations, documenting findings with input from Subject Matter Experts (SMEs), managers, and Quality Assurance (QA). Review all associated raw data and records, determine the sequence of events, and conduct root cause analysis. Develop hypothesis testing plans collaboratively with QA and clients, providing systematic and detailed OOS reports. Work with operations and QA to decide on corrective/preventive action plans for OOS results.
- CAPA Process: Participate in or champion the CAPA process, investigating CAPAs on behalf of Quality Control (QC) and reviewing them according to CAPA SOPs. Ensure timely completion of investigations as per SOP.
- Validation and Audits: Conduct validation or failure investigations as needed. Follow up on corrective actions from internal and external audits, supporting the preparation of responses to external audit reports.
- Client Interaction: Address client requests and complaints effectively, ensuring timely communication regarding any issues that may impact deadlines.
- Deviations Management: Initiate, lead, and investigate deviations, performing root cause analysis and corrective actions in accordance with internal SOPs and regulations.
- Documentation: Write stability protocols as per client requests, review QC methods, validation protocols, or reports of methods or equipment. Perform reviews of calibration records or testing records and conduct impact assessments as necessary.
- Training & Compliance: Train departmental staff on documentation practices, regulatory issues, and corrective actions. Maintain a clean and organized working environment according to laboratory procedures.
- Reporting: Prepare weekly progress reports on assignments and ensure that all training records are current.
- Minimum of a Bachelor's degree in Biology, Biochemistry, or a related field;
- Over 5 years of experience in pharmaceutical or cannabis testing with exposure to root cause investigations and quality management systems.
- Knowledge of OOS investigation regulatory processes is essential.
- LIMS and transfer program experience considered an asset
- GMP and ISO17025 testing experience is required (3 to 5 years)
- Proficient in using root cause analysis tools.
- Strong understanding of scientific principles relevant to the investigations.
- Ability to work under pressure with tight deadlines while managing multiple assignments.
- Excellent written and verbal communication skills.
- Self-starter, ambitious and energetic
- Proficiency in standard office software (Word, Excel, PowerPoint, Outlook).
- Candidates must maintain a proactive attitude towards training and compliance with SOPs while demonstrating attention to detail in all duties performed.