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Business Analyst II
Ref No.: 18-16330
Location: Deerfield IL, Illinois
This project is to deploy third party global workflow, tracking and proofreading tool with integrations to existing internal applications to support Global Labeling.

Main purpose of the job:
- IT Business Analyst
o Analyze business processes.
o Identify, evaluate, develop and/or redesign systems and procedures to meet user requirements.
o Update detailed user requirements for vendor.
o Create/Update system and validation documentation.
o Issue Management- working with the vendor and the users.

- IT Validation Tester
o Write test cases based on user requirements specifications and integration requirements.
o Execute test scripts to ensure the solution functions as expected.
o Raise test defects, as necessary.

Primary responsibilities:
- IT Business Analyst
o Gather, understand and document business objectives, specifications and requirements.
o Define, design, and document business flows and processes.
o Define and articulate business rules required for data accuracy and consistency. Identify and resolve data and documentation quality issues. Act as the primary contact for the data management and/or implementation of system functionality to meet business processes between IT developers and the business.
o Provide functional application support to users.
o Identify, analyze, propose and document appropriate solutions for problems and issues that may impact the project. Identify and understand issues that may impact day-to-day operations and/or project costs. Use technical tools (queries, process maps, etc.) for problem discovery/resolution.
o Understand and follow appropriate SDLC and application processes.
o Create/Update system and validation documentation.
o Communicate status, solutions and concerns. Disseminate information in a timely manner within the team and across functions or teams. Establish and maintain relationships within the business or function.
o Provide cross-functional and business knowledge to develop business system and process alternatives.
o Train others as appropriate on specific area of business or systems expertise. Assist in development of training materials, if needed.
o Other duties as assigned.


- IT Validation Tester
o Ensure system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
o Work closely with the Validation Lead to ensure test scripts are ready for OQ and UAT.
o Write test cases based on user requirements. Revise test cases, as necessary, based on project team feedback.
o Work with business representatives to ensure the test cases reflect business rules and processes.
o Execute test scripts to ensure the system release functions as expected.
o Report defects and problems that arise during system testing.
o Identify and escalate, as necessary, project risks and issues to the Validation Lead and/or Project Manager.
o Other duties as assigned.

Knowledge, skills and/or abilities required:
- Solid knowledge of quality system validation processes.
- Solid knowledge of the application development process.
- Requirements definition and management, business process analysis, system testing and problem resolution.
- Strong communication skills (verbal/written/listening).
- Sense of urgency with strong follow-up skills. Must be detail-oriented, own key tasks, handle moderately complex problems, require minimal direction and be able to work with in a team setting.

Education and experience required:
- Bachelor's degree preferred or relevant work experience in systems or business.
- 7+ years experience in applying information systems solutions to business problems.
- Experience with computer system validation and proven experiencing working on validated projects.
- Experience with using Client ALM.
- Work experience within pharmaceutical or medical device industry preferred; experience in the Regulatory Affairs or labeling disciplines preferred.
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