About this role

Plans and conducts GxP audits (e.g., internal, vendor, site)
Develop 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 to 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
Appropriately escalates any critically identified areas of deficiency in quality and reports those 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
Other duties as assigned

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

Clinical QA Auditor

Key skills