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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.

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IT Consultant, Quality Systems (FTE)

Baxter International

Round Lake, IL or Deerfield, IL

Position Overview

• This position is accountable for the quality of IT project delivery by performing project-applicable Quality Compliance functions in a global environment, and ensuring that the IT system developed meets its intended use.
• The Quality System Consultant is responsible for monitoring compliance to 21 CFR art 11, Annex 11, GxP regulations, Baxter Quality Management System, and other established IT policies/procedures.
• This position will contribute to improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of IT.

Critical Responsibilities

• Responsible for assuring a system/application meets its intended use and is compliant with applicable Baxter procedures.
• Responsible for approving the deliverables required for the development and validation of the computerized system.
• Supports a system owner in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable, and consistent operation of the computerized system.Also, considers risk management.
• Provides indirect leadership to computer system implementation team members.
• Responsible for investigating IT Non-conformances and ensuing IT Corrective Actions and Preventive Actions are effective.
• Approves IT system change requests, problem investigation reports, and computer system periodic reviews.
• Provides internal/external audit support for IT systems.
• Demonstrates leadership and accountability

Key Qualifications

• Excellent analytical and judgment capabilities and communication skills, and the ability to work with both IT management and staff.
• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Ability to make good judgments and quick decisions.
• Solid presentation skills.
• Solid oral and written communication skills and teamwork skills.
• Strong influencing skills.

Education and Experience

• 10+ years’ experience in a quality systems environment, or equivalent work experience
• Computer System Validation experience a must

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.