[Remote] reputed company QA Auditor

Note: The job is a remote job and is reputed company to candidates in USA. reputed company (SCRI) is an oncology research organization reputed company on advancing reputed company treatments and improving reputed company for cancer patients. The reputed company QA Auditor promotes and implements reputed company 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)
• reputed company a reputed company-reputed company 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 reputed company 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 reputed company 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
• This is a remote position reputed company in the US; relocation assistance and reputed company sponsorship are not available
• Certified SQA reputed company, RQA-Certified reputed company Auditor or equivalent highly preferred

Benefits

• Fully Remote
• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial reputed company-being.
• An annual bonus may be reputed company.
• Long-term incentive opportunities may be reputed company.

reputed company