IT Validation Tester - Round Lake, IL

Job Summary:

•  Demonstrate attention to detail and accountability.
•  Be responsible for assuring a system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
•  Identify and escalate, as necessary project risks and issues to the Validation Lead, Business Analyst, and/or Project Manager.
• Be able to prepare reports on defects and problems that arise during system testing.
• Have solid oral and written communication skills and teamwork skills.
• Be a good team player, able to meet deadlines and handle changing priorities.
• Have strong judgment capabilities to clarify requirements when necessary.
• Have the ability to work with IT management, business analysts and technical staff.
•  Have solid experience working with validated systems
• Work with business representatives to ensure the test cases reflect business rules and processes
• Revise test cases as necessary based on project team feedback.
•  Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.
• Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.
• As necessary modify/create Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity

Responsibilities:

•  Minimum BA / BS or relevant work experience in information systems, engineering, science or business. 
• Fluent in written and verbal Japanese. 
•  Highly skilled in Computerized System testing and validation in the healthcare industry. 
• The candidate must have experience with HP ALM Quality Center and understand the SDLC processes. 
•  Experience with TrackWise is a highly desired skill set. Additional skills required include developing operational and performance based test scripts from functional specifications. 
• Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.) 
• Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills. 
•  Excellent communication including written, verbal, and listening skills. 
• Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.

Qualifications:

• Experience level: Experienced
• Education: Bachelors

Skills:

• information systems
• Japanese
• Computerized System testing
• validation
• HP ALM Quality Center
• SDLC
• TrackWise
• IT
• Complaint Management