Principal Quality Assurance Auditor
July 26
🏡 Remote – New York
Description
• 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. • Serve as a subject matter expert for clinical project teams • Support the Quality Management System including SOPs, training and CAPA • Attends project meetings, representing Quality • Host client/sponsor audits and support regulatory inspections
Requirements
• 5 years of experience • Working knowledge of GCP/ICH guidelines and FDA regulations and standards • Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. • Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative • Availability to travel up to 25% domestically and/or internationally
Benefits
• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation
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