Healthcare QA Specialist

This position monitors the overall Quality System status of the distribution center, ensuring compliance to drug, medical device, and local regulations, and maintaining quality processes through procedures, training, and inspections.

Requirements

• Ensures all staff is trained in their respective job functions, including GMP
• Writes and revises Standard Operating Procedures as required
• Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings
• Coordinate or assist with corrective actions and preventative measures
• Communicates with clients and provides information during external audits
• Liaises with Health Canada officials during regulatory audits
• Provides feedback and assistance to Customer/Client QA related questions and concerns
• Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation
• Investigates discrepancies and problems, and advise the appropriate individuals of the findings
• Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes
• Completes NCR reports and change control requests and provide necessary follow-up
• Performs maintenance, support, and continuous improvements of Quality Systems