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Job DescriptionJob Description

Job Function

The Quality Systems Specialist is primarily responsible for the following:

- Designs, develops, and implements internal auditing programs and procedures consistent with the organization’s requirements
- Performs Internal Audits, to ensure that procedures are available and adhered to according to requirements for maintaining ISO/IEC 17025:2017 accreditation and GLP (Positive Laboratory Practices) recognition.
- Performs GLP inspections to ensure that GLP studies are completed according to OECD and/or FDA GLP requirements.
- Reports audit findings to Director QA or designate and conducts post-audit meetings as necessary.
- Performs/ reviews non-conformance investigations to ensure the non-conformance has been addressed and full and proper resolution has been documented.
- Issues corrective actions in response to Quality Systems activities, tracking the progress and verifying the implementation and effectiveness of corrective actions
- Completes evaluation of supplier quality
- Arranges and prepares for external audits, assists with pre and post-assessment activities. Coordinates necessary action on audit findings corrective/preventive actions, and responds to related findings externally.
- Reviews/ Evaluates laboratory performance in Proficiency testing/ Inter-laboratory studies
- Coordinates/ performs refresher training (ISO 17025 and GMP) for laboratory staff.
- Reports quality metrics regularly to top management
- Responsible for quality projects as assigned





Primary Responsibilities

- schedule and perform internal audits
- Participate in external audits
- review and investigate non-conformances, client complaints
- Issue and monitor corrective actions
- Evaluate supplier quality
- Review, approve, and maintain equipment qualification records
- Perform Administrative Tasks
- The employee shall implement the Laboratory Quality Policy and perform their duties in accordance to existing job specific requirements and procedures
- Compliance to Health & Safety policies and procedures; wear required Personal Protective equipment at all times while in the laboratory
- Other duties as assigned

Education

- Minimum Bachelor of Science in a technical discipline (Chemical or Biological Sciences)

Experience

- 3+ years experience in an auditor role in ISO 17025 accreditation, GLP and/or GMP regulated environment, with proficiency in quality assurance systems and documentation
- Excellent attention to detail, organizational, prioritization and problem-solving skills
- Technical experience in the use, calibration of various analytical instrumentation commonly found in a commercial laboratory.
- Proficient in written and spoken English. excellent communication, conflict resolution
- Proficient in MS Office (Excel, Outlook, Word); Computer literate. Familiarity with IT systems, electronic submission systems, data and document management system
- Or as determined by Human Resources and Department Manager/Supervisor

Apply on Kit Job: kitjob.ca/job/2g9kf4

📌 Quality Assurance Specialist 1 (Kitchener)
🏢 Certified Laboratories
📍 Kitchener