Clinical Quality Assurance Auditor
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Job Description
Quality Assurance Auditor conducting GxP audits and improving quality processes within SCRI, a leading oncology research organization.
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.
Requirements:
- 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
- Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred.
Benefits:
- Comprehensive benefits to support physical, mental, and financial well-being
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