Note: The job is a remote job and is open to candidates in USA. Sarah Cannon Research Institute (SCRI) is an oncology research organization focused on advancing clinical treatments and improving outcomes for cancer patients. The Clinical QA Auditor promotes and implements quality initiatives by planning and conducting GxP audits, assessing processes, reporting observations, and following up on corrective actions and areas of non-compliance.
Responsibilities
- 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
Skills
- Bachelors 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
- This is a remote position based in the US; relocation assistance and visa sponsorship are not available
- Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred
Benefits
- Fully Remote
- Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being.
- An annual bonus may be offered.
- Long-term incentive opportunities may be offered.
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