Clinical QA Auditor - Remote US
Sarah Cannon Research Institute•Work at Home - Tennessee, USA (WTNA), TN
•Remote
About The Position
Our Quality Assurance Auditor will be responsible for promoting the development and implementation of quality initiatives within SCRI through conduct of audits. This is a remote position based in the US; relocation assistance and visa sponsorship are not available.
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
Nice To Haves
- Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred.
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.
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
