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Job Description: Job Summary: This position monitors the overall Quality System status of the distribution center in staffing for Quality Assurance Local Dept. This position acts in compliance with drug, medical device, and local regulations. Ensures quality processes are maintained through the implementation of procedures, training, and regular inspections.
Responsibilities: Ensures all staff is trained in their respective job functions, including GMP.Revise and distribute Standard Operating Procedures as required.Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings, claims, and temperature report. Coordinate or assist with corrective actions and preventative measures QA Specialist and QP-RP.Communicates with clients and provides information during external 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.Completes reports and change control requests and provide necessary follow-up.Support all Staff in maintenance, and continuous improvements of Quality Systems, integration process.Qualifications: Pharmaceutical, healthcare - PreferredQuality Assurance experience - PreferredBachelor's Degree in Pharmacy- CTF requiredISO 9001/13485/14001/18001 preferredEmployee Type: Permanent
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