Quality Assurance Specialist

Quality Systems Specialist
Job Function

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 (Good 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

Salary Range for Pay Transparency
$25 CAD - $30 CAD

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