Clinical IT Quality Control Analyst

Job not on LinkedIn

🔥 11 minutes ago

🌲 North Carolina, Tennessee – Remote

🌲 North Carolina – Remote 🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 to ensure compliance with 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 related to software validation, quality management, and GxP • Oversee quality activities related to software, process, and data integrity validation • 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 through 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 impacting validated systems and/or 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 • Experience in GCP clinical space, such as CRO or SMO, highly preferred • 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 and knowledge of EU regulations, e.g., 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 sites' 21 CFR Part 11 requirements and software validation principles • Must be based in the United States • Visa sponsorship is 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 • Equity may be included in compensation • Relocation assistance is not available • Visa sponsorship is not available