Analyst – Computer Software Validation

October 2

🧀 Wisconsin – Remote

Although this job is listed in Wisconsin, this company may be open to hiring remote in other states.

💵 $60k - $100k / year

⏰ Full Time

🟢 Junior

🧐 Analyst

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Veeva Systems

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SaaS • Healthcare Insurance • Pharmaceuticals

Veeva Systems is a cloud-computing company focused on the global life sciences industry. It provides software, data, and consulting services to streamline research and development, quality management, regulatory operations, and commercial processes. Veeva's solutions encompass clinical trials, regulatory submissions, drug safety management, and commercial execution to support life sciences enterprises in their mission to improve and extend life.

1001 - 5000 employees

☁️ SaaS

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Participate in RTSM requirement gathering sessions with clients and RTSM team members • Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format • Ensure requirements are adequately tested following a risk-based approach • Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices • Manage Validation testing cycles and resolution of issues and enhancement requests • Maintain change control documentation to ensure ongoing validation of the RTSM system • Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements • Support customers as needed in RTSM validation activities

🎯 Requirements

• 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.) • Working knowledge of software development cycle (SDLC) • Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11 • Exceptional attention to detail • Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels • Experience with authoring automation testing using Selenium

🏖️ Benefits

• Medical, dental, vision, and basic life insurance • Flexible PTO and company paid holidays • Retirement programs • 1% charitable giving program