Clinical QA Auditor

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🔥 0 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• 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

• Bachelor's 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