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Principal Specialist, Quality Assurance

Cardinal Health · Indianapolis, Indiana, US

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and serv...

Job description

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary: The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This job reviews inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set threshold methodologies across the organ...