Job Title: IT Business Systems Analyst
Location: Mundelein, IL
Work Authorizations: Authorized to Work
Position Type: Contract
Duration: 12 Primary Skills: Business Analyst, GxP, FDA regulations
Secondary Skills:
Description:
This is Hybrid role 3 days onsite in Mundelein, IL
Job Summary
Responsible for collaborating with business partners and identifying business problems.
Recommends solutions with new or existing processes, applications, systems,programs, or software.
Minimum Job Requirements
Education: Typically requires a Bachelor''s degree in a business or IT-related field.
Certification / Licensure
Not required but familiarity with GxP, FDA regulations, or validation frameworks is strongly preferred.
Work Experience
• At least 4+ years of experience in system analysis and configuration, preferably in Quality / regulated environments, such as:
• Experience working with GxP applications (EQMS, Design Controls, Risk management and Post market surveillance)
• Dashboard development experience using Power BI, Tableau, or similar tools
• Utilizing SQL or similar tools for data analysis and quality reporting
• Analyzing and reporting Quality data to identify trends, compliance risks, and improvement opportunities
• Experience working in Agile/Scrum environments
• Experience applying project management and validation methodologies
Knowledge/ Skills / Abilities
Strong understanding of Quality processes and regulatory requirements (FDA, ISO, GxP principles)
• Broad knowledge of hardware, software, and integration patterns (APIs, ETL, event-driven)
• Experience documenting complex processes with traceability (requirements → design → testing)
• Strong time management skills with the ability to manage multiple Quality initiatives
• Experience working with cross-functional teams across IT, Quality, Compliance, and Data teams
• Ability to independently assess issues and drive resolution in regulated environments
• Strong influencing, leadership, and stakeholder management skills
• Strong interpersonal and relationship management abilities
• Strong
analytical and problem-solving skills with attention to detail (audit readiness
mindset)
•Self-motivated with a demonstrated bias for action
Preferred Qualifications
Work Experience
• Power Platform (Power Apps, Power Automate, Dataverse)
• EQMS and PLM systems (PTC)
• Data archiving and retention strategies for regulated systems
• Integration platforms such as WSO2 (API), Talend, etc.
• Validation lifecycle (CSV - Computer System Validation)
• Data integrity and audit trail concepts
• Experience with advanced analytics, machine learning, or predictive Quality analytics
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