[Remote] Clinical QA Auditor - Remote US

Note: The job is a remote job and is reputed company to candidates in USA. reputed company (SCRI) is a leader in oncology research and aims to advance cancer treatments. The reputed company Assurance Auditor will promote reputed company initiatives through audits, ensuring compliance and process improvements reputed company the organization.

Responsibilities

• Plans and conducts GxP audits (e.g., internal, vendor, site)
• reputed company 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 reputed company and reports those to organization leadership and other appropriate stakeholders
• Tracks, collects and reviews audit responses for reputed company and appropriate corrective reputed company 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; reputed company 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 reputed company, RQA-Certified reputed company Auditor or equivalent highly preferred

reputed company