QA Specialist - UPS Healthcare

This position monitors the overall Quality System status of the distribution center and acts in compliance to drug, medical device, and local regulations.

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.
• QPIC designation duties.