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.
• 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.
• Conduct internal audits of quality systems.
• Coordinate and conduct investigator site audits.
• Participate in computer systems validation projects.
• Provide QA consultation and support to project teams.
• Monitor quality systems and provide feedback on compliance risks.

Requirements

• 4 years industry experience.
• Clinical research experience in a non-QA role considered.
• Working knowledge of GCP/ICH guidelines and FDA regulations.
• Bachelor’s degree in a science or healthcare-related field.
• 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 and paid time off for sick leave and vacation.