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Principal Quality Auditor GCP at Precision for Medicine. Location Information: Remote, United States. . . 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 RMTA0LjE1NC4yMDcuNTI= when applying to show you read the job post completely (#RMTA0LjE1NC4yMDcuNTI=). 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..