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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:
- 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.