Healthcare Quality Assurance Specialist

2 months ago

Burlington, Ontario, Canada CB Canada Full time

Job Summary

The Healthcare Quality Assurance Specialist plays a crucial role in ensuring the quality and compliance of our clients' products and services. This position is responsible for leading assigned teams in all QA compliance tasks associated with the migration of existing clients from our current system to a new warehouse management system.

Key Responsibilities:

  • Owns the compliance tasks associated with the system migration, ensuring seamless transition and minimal disruption to our clients.
  • Provides Quality and Regulatory requirements for standard procedures, ensuring adherence to industry standards and best practices.
  • Promotes Issue resolution, risk management, continuous improvements, and project initiatives, driving business growth and excellence.
  • Assists with creation, revision, and approvals of Controlled Documents (SOP/WI/Forms), ensuring accuracy and compliance.
  • Provides investigation and Non-conformance reporting, including development of proactive strategies for preventing recurrence, minimizing risks and ensuring quality.
  • Change control management, providing Quality and Regulatory compliance guidance to clients and internal staff, ensuring alignment with industry standards.
  • Performs direct reports responsibilities, including risk assessment, task delegation, performance evaluation, skills development, constructive feedback, formal performance review, and formal career development, ensuring team members are equipped to excel in their roles.
  • Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings, ensuring compliance and quality.
  • Communicates with clients and provides information during external audits, ensuring transparency and cooperation.
  • Liaises with regulatory officials during audits, ensuring compliance and adherence to industry standards.
  • Provides feedback and assistance to Customer/Client QA related questions and concerns, ensuring timely and effective resolution.
  • Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation, identifying areas for improvement and implementing changes as needed.
  • Investigates discrepancies and problems, and advises the appropriate individuals of the findings, ensuring prompt resolution and minimizing risks.
  • QPIC designation duties, ensuring expertise and knowledge in quality assurance and regulatory compliance.

Requirements:

  • Pharmaceutical, healthcare, or food industry experience is preferred, with a strong understanding of quality assurance and regulatory compliance.
  • Quality Assurance experience is preferred, with a proven track record of ensuring compliance and quality in a fast-paced environment.
  • Bachelor's Degree in Science related field (or internationally comparable degree) is required, with a strong foundation in quality assurance and regulatory compliance.
  • QPIC/AQPIC designation is preferred, demonstrating expertise and knowledge in quality assurance and regulatory compliance.

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