Healthcare QA Specialist

Job Summary
This position monitors the overall Quality System status of the distribution center, ensuring compliance with drug, medical device, and local regulations. Maintains quality processes through procedures, training, and regular inspections.

Job Type: Full Time- Permanent.

Workdays: Monday to Friday (must be able to work ALL 5 days of the week).

Shift Hours: 9:00 AM to 5:30 PM (must be able to work a minimum of 40 hrs. per week)

Shift Duration: 8 hours a day (requires flexibility with Start and Finish time).

Work Location: 4150 MAINWAY BURLINGTON, ON L7L 0A7 Canada

Responsibilities:

• Ensure all staff are trained in their respective job functions, including GMP.
• Write and revise Standard Operating Procedures as needed.
• Conduct regular process adherence checks, document findings.
• Communicate with clients and provide information during external audits.
• Liaise with Health Canada officials during regulatory audits.
• Provide feedback and assistance to Customer/Client QA-related questions and concerns.
• Monitor processes and systems within the Department to ensure regulatory compliance and effective operation.
• Investigate deviations advising appropriate individuals of findings and develop corrective and preventive actions.
• Initiate and manage change control requests, providing necessary action plans and change effectiveness verifications.
• Perform QPIC/AQPIC designation duties.

Qualifications:

• Pharmaceutical, healthcare, or food industry experience – Preferred.
• Quality Assurance experience – Preferred.
• Bachelor’s Degree in a science-related field (or with assessed international equivalency) – Preferred.
• QPIC/AQPIC designation – Preferred.