Quality Assurance Specialist

Certified Group; Kitchener; Sur place; CAD 34 440 - 41 328; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Internal audits

Quality assurance

English proficiency

Problem-solving

Documentation

Formation

BSc in Chemical/Biological Sciences

Outils

MS Office

Description du poste

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

By 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 Policy

We are an Equal Opportunity Employer and make employment decisions without regard to protected characteristics under applicable law.