Clinical QA Auditor - Remote

About the Role

By joining the growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will help advance oncology treatments and improve outcomes for cancer patients worldwide. The Quality Assurance Auditor will promote the development and implementation of quality initiatives through the conduct of audits.

• Plan and conduct GxP audits (internal, vendor, site).
• Develop a risk-based audit plan to prioritize audit activities.
• Interview key staff to assess process completion, support inspection readiness, and communicate potential observations or process improvement opportunities.
• Document audit observations and process improvement opportunities in written audit reports distributed to the appropriate personnel.
• Appropriately report any critically identified areas of deficiency in quality to organizational leadership and stakeholders.
• Track, collect, and review audit responses to ensure timely and appropriate corrective action is taken as follow-up to identified non‑compliance until audit closure.
• Perform other duties as assigned.

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

SCRI is one of the world’s leading oncology research organizations conducting community‑based clinical trials. The institute has conducted more than 850 first‑in‑human clinical trials and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.