Quality Assurance Specialist

Certified Group; Kitchener; On-site; CAD 34,440 - 41,328; Full time

Job summary

Certified Group in Canada is seeking a Quality Systems Specialist to design, implement, and oversee internal auditing programs to maintain ISO/IEC 17025:2017 accreditation and GLP/GMP compliance in our laboratory operations.

You will schedule internal audits, participate in external audits, review non-conformances, drive corrective actions, and ensure supplier quality and equipment qualification records are kept up to date; strong English and MS Office skills are essential.

Qualifications

• Bachelor of Science in a technical discipline required (Chemical or Biological Sciences).
• 3+ years in an auditor role in ISO 17025, GLP or GMP regulated environment.
• Attention to detail, organizational, prioritization and problem-solving skills.
• Proficient in written and spoken English; strong documentation skills.
• Familiarity with IT systems and electronic document management.

Responsibilities

• Schedule and perform internal audits.
• Participate in external audits.
• Review and investigate non-conformances; implement corrective actions.
• Evaluate supplier quality and maintain equipment qualification records.
• Perform administrative tasks related to quality systems.
• Ensure compliance with Health & Safety policies in the lab.

Skills

Internal audits

Quality assurance

English proficiency

Problem-solving

Documentation

Education

BSc in Chemical/Biological Sciences

Tools

MS Office

Job description

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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