Philadelphia, Pennsylvania, United States of America
Full Time
5 days ago
Visa Sponsor
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.