Clinical QA Auditor

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Plans and executes GxP audits (including internal, vendor, and site audits).

• Develops a risk-based audit strategy to prioritize audit activities.

• Engages with key personnel to evaluate process completion, ensure inspection readiness, and identify any potential observations or opportunities for process enhancement.

• Communicates findings and suggestions for process improvements through a written audit report shared with relevant personnel.

• Properly escalates critically identified deficiencies in quality and informs organizational leadership and other relevant stakeholders.

• Monitors, gathers, and reviews audit responses to ensure timely and adequate corrective actions are taken in response to identified non-compliance until the audit is concluded.

• Performs additional duties as assigned.

⛳️ Requirements

• A Bachelor's Degree is required.

• A minimum of 3 years of experience in a regulated clinical research setting is required.

• Experience in Quality Assurance Auditing is essential.

• Familiarity with FDA regulations and Good Clinical Practice (GCP) is required.

• Understanding of 21 CFR Part 11 requirements and software validation principles is necessary.

• Certification as a SQA Professional, RQA-Certified Quality Auditor, or an equivalent qualification is highly preferred.

🏝️ Benefits

• Comprehensive benefits designed to support physical, mental, and financial well-being.