About this role
Role Overview
- Monitors the overall Quality System status of the distribution center.
- Acts in compliance to drug, medical device, and local regulations.
- Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections.
- 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 advises 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 provides necessary follow-up.
- Performs maintenance, support, and continuous improvements of Quality Systems.
- QPIC designation duties.
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
- Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.
Benefits
- Health insurance
- Retirement plans
- Paid time off