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Lab IT Systems Specialist
2 weeks ago
Lab System Specialist
as part of the
IT team based in
Somerset, NJ.
Role Overview
The Lab IT Systems Specialist will be responsible for administrating and maintaining LIMS, ELN, and various lab applications used in R&D, pre-clinical, clinical operations and technical development.
Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.
Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.
Execute standardization plan and contribute to identifying opportunities to standardize
Test changes/enhancements through dry runs and receive feedback from lab users, when required.
Setup verification testing as appropriate for the lab system.
Assist with User Acceptance Testing for system functionality changes.
Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.
Provide ad hoc support to users for issues/questions on the lab system.
Communicate technical issues and activity status updates to team members/direct management.
Process user account requests for system access.
Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.
Provide support for internal compliance and regulatory agency inspections as required First point of contact for business partners.
Requirements
Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years' experience
Knowledge and in depth understanding of analytical techniques preferred.
Proficient knowledge of a lab system such as LIMS, ELN, SDMS, etc., understanding of system interfaces and impact of changes to each other a plus.
Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
Ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.
Respond to system issues and troubleshoot to identify cause.
Ability to interpret and apply GxPs, regulatory requirements
Must have knowledge of software development lifecycle (SDLC) and of computer systems validation (CSV)
Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed.
Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.
Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
Strong interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
Ability to work on multiple complex projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations
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