Serves as global SME for LIMS and trains global lab personnel to adopt the system.
Leads LIMS site adoption globally.
Collaborate with team members site users as well as IT team to gather user requirements as well as
update/enhance and/or develop the system within defined regulatory and company requirements.
Interprets and analyzes data; performs basic data analysis.
Review user requirement specification functional documents provided by IT.
Develop LIMS global procedure/user manual.
Monitor site with implementation of LIMS and ensures the system is used globally to its intended
capabilities. Presents basic data to internal department.
Troubleshoots issues with LIMS and interacts with users and IT team to successfully resolve issues.
Review and prioritize all LIMS system changes and enhancement requests with help from management and
IT.
Ensure software systems meet the requirements of 21 CFR part 11 and companys requirements.
Optimizes workflows and improves processes.
On annual basis reviews licenses available for the system versus requested and communicates needs to
management.
Develop LIMS expertise at global manufacturing labs.
Provide support during regulatory and internal audits.