Principal Quality Assurance Auditor

Provide senior oversight and subject matter expertise to quality and compliance activities • Support the Q&C Management team, Q&C team members, and project teams during all stages of a clinical study • Serve as a subject matter expert for clinical project teams • Develop and implement concepts and/or techniques to achieve objectives • Understand Precision processes and functional SME organization to work through complex tasks independently • Support the Quality Management System including SOPs, training and CAPA • Attend project meetings, representing Quality • Process and maintain documentation for controlled documents • 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 • 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