Precision for Medicine is hiring a
Remote Principal Quality Auditor GCP
\n \n\nPosition Summary: \n\nThe 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. \n\nEssential functions of the job include but are not limited to: \n\n\n* Serve as a subject matter expert for clinical project teams \n\n* Uses ability and specialized skill to complete difficult tasks. Develops and implements concepts and/or techniques to achieve objectives \n\n* Understands Precision processes and functional SME organization to work through complex tasks independently to resolution \n\n* Support the Quality Management System including SOPs, training and CAPA \n\n* Attends project meetings, representing Quality. Reviews project plans and provides compliance guidance on complex issues independently. \n\n* Process and maintain documentation for controlled documents, as required \n\n* Develop and administer training for employees and/or consultants \n\n* Host client/sponsor audits and support regulatory inspections \n\n* Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted \n\n* Coordinate and conduct internal audits of quality systems \n\n* Coordinate and conduct investigator site audits \n\n* Coordinate and conduct trial master file audits \n\n* Participate on computer systems validation projects and systems change control process \n\n* Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement \n\n* Maintains Q&C trackers, databases, metrics, and files \n\n* Follow applicable regulations and standards.\n\n\n \n\n#Location\nRemote, United States
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