Clinical IT Quality Control Analyst

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🔥 0 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

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

• Oversee quality control and assurance of software, process, and data integrity validation processes • Provide guidance and support to operational teams on GxP, 21 CFR Part 11, and regulatory requirements • Work with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts • Support research operations and IT in interpreting corporate and regulatory requirements • Review validation lifecycle documents, including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports • Provide quality guidance for preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols • Assist with periodic review of system documentation • Provide quality review of changes affecting validated systems and processes • Perform other duties as assigned

🎯 Requirements

• Bachelor's Degree required; professional qualified experience may be substituted for education • Direct experience in a QA/QC role in computerized systems validation • 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused on FDA GxP requirements for systems, 21 CFR Part 11, and FDA software validation guidelines • Experience in the GCP clinical space, such as CRO or SMO, highly preferred • Experience and knowledge of EU regulations, such as Annex 11, preferred • Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH • Knowledge of pharmaceutical, biologics, CRO, and clinical site 21 CFR Part 11 requirements and software validation principles • Must be based in the US • Relocation assistance and visa sponsorship are not available

🏖️ Benefits

• Comprehensive benefits supporting physical, mental, and financial well-being • Competitive compensation package • Annual bonus or long-term incentive opportunities may be offered • Resources and opportunities to grow and be your best • Balanced life