Medical Laboratory Quality Assurance Specialist

4 days ago


Vaughan, Ontario, Canada Benton Roofing Full time
About the Role

We are seeking a highly skilled and experienced Medical Laboratory Quality Assurance Specialist to join our team at Benton Roofing. This is a unique opportunity for a qualified professional to oversee the implementation and maintenance of quality systems, ensuring compliance with regulatory standards and driving continuous improvement initiatives.

Key Responsibilities
  • Audit Management:
    • Lead and manage all vendor, internal, customer, and FDA regulatory audits.
    • Prepare detailed audit reports and oversee the implementation of corrective actions.
    • Ensure continuous compliance with all regulatory and accreditation requirements.
  • ISO/IEC 17025 Accreditation:
    • Lead and manage ISO/IEC 17025:2017 accreditation audits.
    • Oversee the implementation of policies and procedures to maintain accreditation.
    • Ensure laboratory practices align with international quality standards.
  • Project & Personnel Management:
    • Supervise and manage the quality team, providing guidance and leadership.
    • Oversee multiple quality-focused projects to enhance laboratory operations.
    • Foster a culture of continuous improvement and compliance.
  • SOP and Documentation Management:
    • Author, review, and revise Standard Operating Procedures (SOPs) to ensure consistency and accuracy.
    • Oversee laboratory notebooks, equipment logbooks, calibration records, and raw data documentation.
    • Ensure all documentation aligns with regulatory requirements and best practices.
  • Training & Proficiency Programs:
    • Oversee the development and execution of our training programs for quality assurance.
    • Manage the Proficiency Testing Program to ensure compliance and staff competency.
    • Develop and implement quality training initiatives for laboratory personnel.
  • Collaboration & Quality Improvement:
    • Work closely with laboratory management to address corrective actions and client complaints.
    • Champion quality improvements within the laboratory through proactive initiatives.
    • Collaborate with stakeholders to drive innovation in quality management systems.
  • Regulatory Compliance & Reporting:
    • Ensure adherence to GLP, GMP, and ISO regulations in all quality assurance functions.
    • Prepare and present Laboratory Quality Reports to the Director of Quality and Director of Operations.
    • Stay informed on regulatory changes and implement necessary updates.
  • Client & Business Development Support:
    • Assist Business Development with quality-related client inquiries.
    • Ensure that client quality expectations and regulatory requirements are met.
    • Support external client interactions regarding quality assurance matters.
  • Meetings & Professional Development:
    • Lead and participate in Quality Management meetings to drive continuous improvement.
    • Engage in professional development opportunities as directed by the Director of Quality.
    • Stay current with industry trends and regulatory updates.
    • Perform additional duties as assigned by the Director of Quality.


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