Quality Systems SpecialistJob FunctionDesigns, develops, and implements internal auditing programs and procedures consistent with the organization's requirementsPerforms 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 actionsCompletes evaluation of supplier qualityArranges 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 studiesCoordinates/ performs refresher training (ISO 17025 and GMP) for laboratory staff.Reports quality metrics regularly to top managementResponsible for quality projects as assignedPrimary ResponsibilitiesSchedule and perform internal auditsParticipate in external auditsReview and investigate non-conformances, client complaintsIssue and monitor corrective actionsEvaluate supplier qualityReview, approve,



and maintain equipment qualification recordsPerform Administrative TasksThe employee shall implement the Laboratory Quality Policy and perform their duties in accordance to existing job specific requirements and proceduresCompliance to Health & Safety policies and procedures; wear required Personal Protective equipment at all times while in the laboratoryOther duties as assignedEducationMinimum Bachelor of Science in a technical discipline (Chemical or Biological Sciences)Experience3+ years experience in an auditor role in ISO 17025 accreditation, GLP and/or GMP regulated environment, with proficiency in quality assurance systems and documentationExcellent attention to detail, organizational, prioritization and problem‐solving skillsTechnical experience in the use, calibration of various analytical instrumentation commonly found in a commercial laboratory.Proficient in written and spoken English. excellent communication, conflict resolutionProficient in MS Office (Excel, Outlook, Word); Computer literate. Familiarity with IT systems, electronic submission systems, data and document management systemOr as determined by Human Resources and Department Manager/SupervisorSalary Range for Pay Transparency$25 CAD - $30 CADBy applying, you acknowledge that Certified Group will process your personal information for recruitment and hiring purposes in accordance with our Applicant Privacy Policy. California residents may review additional information about how we collect and use personal information, including retention and rights, in our California Notice at Collection. To view our Privacy Policy, click the link here: Certified Group Privacy PolicyWe are an Equal Opportunity Employer and make employment decisions without regard to protected characteristics under applicable law.

📌 Quality Assurance Specialist (Kitchener)
🏢 Certified Group
📍 Kitchener