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Position Summary:
The Configuration Analyst is part of the Global Product Lifecycle Management team that facilitates product and process changes at Illumina. This position will manage change and configuration activities from launch to end-of-life. The Configuration Analyst will interface with individuals from Manufacturing, Engineering, Quality, Regulatory, Supply Chain, ensuring a positive experience while delivering compliant changes.
Position Responsibilities:
Support Change, Item, BOM, and Document Management within Product Lifecycle Management (PLM) system. Develop deep end-to-end understanding of document and item lifecycle and requirements.
Act as a quality gatekeeper for change records and controlled documentation, ensuring each submission is accurate, complete, consistent, and audit-defensible in alignment with procedures and work instructions.
Provide feedback and partner with Change Owners to enhance changes.
Perform setup of material master data in ERP system.
Develop implementation plans.
Troubleshoot and resolve issues in the change/configuration process and system.
Support or lead training activities to up-level change owner user base in all aspects of change management process.
Monitor change queue and prioritize work to continuously meet business needs and service expectations.
Execute small-to-medium projects that improve effectiveness of change management (process optimization, training content, reporting automation, system enhancements).
Prepare, report and deliver the expected department KPIs.
Support internal and external audits, including preparation of documentation and providing relevant change data. Participate in audit backroom support.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Position Requirements:
Typically requires a minimum of 2 years of related GxP environment experience
Bachelor's Degree in an Engineering or Science discipline
Proficient in using Microsoft office tools (Words, Excel and PowerPoint) and Adobe for information/report generation
Experience with PLM or Document Control software
Experience with ERP systems preferred
Experience quality regulation standards, ISO 13485 preferred
Self-starter, organized, attention to detail, ability to work independently and in a team environment.
Verbal and written communications are clear and understandable.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
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