Clinical QA Auditor - Remote US

About the role

Our Quality Assurance Auditor position is a remote role based in the US. While relocation assistance and visa sponsorship are not available, we offer a competitive compensation package that includes a total rewards package designed to support the physical, mental, and financial well-being of our colleagues.

Responsibilities

• Plans and conducts GxP audits (e.g., internal, vendor, site)
• Develops a risk-based audit plan to determine the priorities of audit activities
• Conducts interviews with key staff to assess process completion, support inspection readiness, and communicate any potential observations or process improvement opportunities
• Communicates audit observations and process improvement opportunities through a written audit report distributed to the appropriate personnel
• Escalates any critically identified areas of deficiency in quality and reports them to organization leadership and other appropriate stakeholders
• Tracks, collects, and reviews audit responses for timely and appropriate corrective action as follow-up to identified areas of non-compliance until audit closure

Qualifications

• Bachelor's Degree required
• 3+ years' work experience in a regulated clinical research environment required; Quality Assurance Auditing experience required
• Work experience with FDA regulations and GCP is required
• Knowledge of 21 CFR Part 11 requirements and software validation principles
• Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred