Analytical Laboratory Investigator - Eurofins Experchem Laboratories Inc

The role involves leading investigations related to Out of Specification (OOS) results deviations and Corrective and Preventive Actions (CAPA) within a cannabis testing laboratory. The candidate will ensure adherence to Standard Operating Procedures (SOPs) and regulatory guidelines while conducting daily OOS investigations.

Responsibilities Include:

• 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.

Qualifications :

• Minimum of a Bachelors 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)

Skills:

• 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.
• Selfstarter 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.

Working Conditions: This position is based in a laboratory environment; significant time spent standing at a bench working with chemicals and biologicals and in a timesensitive production role. Lifting requirements of up to 30lbs on a regular basis. Extra hours weekends and evenings will be required.  Candidates currently living within a commutable distance of the GTA are encouraged to apply.

Additional Information :

At Eurofins we offer excellent fulltime 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 email a request via the website at www.eurofins.

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 www.eurofins

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.

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Remote Work :

No

Employment Type :

Fulltime