Principal Quality Auditor GCP

Position Summary: The Principal Quality Auditor is responsible for providing senior oversight and subject matter expertise to quality and compliance activities, supporting the Q&C Management team, Q&C team members, and the project teams during all stages of a clinical study. Essential functions of the job include but are not limited to: Serve as a subject matter expert for clinical project teams Uses ability and specialized skill to complete difficult tasks. Develops and implements concepts and/or techniques to achieve objectives Understands Precision processes and functional SME organization to work through complex tasks independently to resolution Support the Quality Management System including SOPs, training and CAPA Attends project meetings, representing Quality. Reviews project plans and provides compliance guidance on complex issues independently. Process and maintain documentation for controlled documents, as required Develop and administer training for employees and/or consultants Host client/sponsor audits and support regulatory inspections Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted Coordinate and conduct internal audits of quality systems Coordinate and conduct investigator site audits Coordinate and conduct trial master file audits Participate on computer systems validation projects and systems change control process Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement Maintains Q&C trackers, databases, metrics, and files Follow applicable regulations and standards. Please mention the word **REWARDINGLY** and tag RMjYwNzo1MzAwOjIwZDo3ZDAwOjo= when applying to show you read the job post completely (#RMjYwNzo1MzAwOjIwZDo3ZDAwOjo=). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.