Healthcare Quality Assurance Specialist
2 months ago
Job Summary
The Healthcare Quality Assurance Specialist plays a crucial role in ensuring the compliance of assigned teams with quality assurance standards associated with the migration of existing clients from GWS to the new warehouse management system.
Key Responsibilities:
- Owns the compliance tasks associated with the system migration, ensuring seamless transition and minimal disruption to business operations.
- Provides quality and regulatory requirements for standard procedures, ensuring adherence to industry best practices.
- Promotes issue resolution, risk management, continuous improvements, and project initiatives, fostering a culture of excellence within the organization.
- Assists with creation, revision, and approvals of controlled documents, including SOPs, WIs, and forms, ensuring accuracy and compliance.
- Provides investigation and non-conformance reporting, including development of proactive strategies for preventing recurrence, minimizing downtime and optimizing productivity.
- Change control management, ensuring that all changes are properly documented, approved, and implemented, maintaining the integrity of the system.
- Provides quality and regulatory compliance guidance to clients and internal staff, ensuring that all stakeholders are aware of and adhere to 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 that all team members are equipped to excel in their roles.
- Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings, identifying areas for improvement and implementing corrective actions.
- Communicates with clients and provides information during external audits, ensuring that all stakeholders are informed and prepared.
- Liaises with regulatory officials during audits, ensuring that all compliance requirements are met and that the organization is in good standing.
- Provides feedback and assistance to customer/client QA-related questions and concerns, ensuring that all stakeholders are satisfied with the level of service provided.
- Monitors the processes and systems within the department to ensure regulatory compliance and effective operation, identifying areas for improvement and implementing corrective actions.
- Investigates discrepancies and problems, and advises the appropriate individuals of the findings, ensuring that all issues are addressed in a timely and effective manner.
- QPIC designation duties, ensuring that all quality and regulatory requirements are met and that the organization is in good standing.
Requirements:
- Pharmaceutical, healthcare, or food industry experience - Preferred
- Quality assurance experience - Preferred
- Bachelor's degree in science-related field (or internationally comparable degree) required - Preferred
- QPIC/AQPIC designation - Preferred
CB Canada is a diverse and equal opportunity employer. We are committed to providing a work environment that is inclusive and respectful of all employees. If workplace accommodation is needed, please advise our HR representatives.
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