Senior Quality Auditor - Remote

Overview

The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. Responsible for providing oversight and subject matter expertise to quality and compliance activities, supporting project teams during all stages of a clinical study.

In Short

• Support the Quality Management System including SOPs, training and CAPA.
• 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.
• 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.
• Provide QA consultation and support to assigned project teams internally and externally.

Requirements

• 4 years industry experience.
• Clinical research experience in a non-QA role considered.
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
• Bachelor’s degree in a science, healthcare, or related field of study.
• Availability to travel up to 25% domestically and/or internationally.

Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.