Note: The job is a remote job and is open to candidates in USA. Sarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing therapies for patients. The Quality Assurance Auditor will be responsible for promoting quality initiatives through the conduct of audits and ensuring compliance within the 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
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
- Certified SQA Professional, RQA-Certified Quality Auditor or equivalent highly preferred
Benefits
- Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package determined by performance, experience and skills, equity, regular job market evaluations, and geographical markets
- Other compensation, such as an annual bonus or long-term incentive opportunities may be offered
Company Overview