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.

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