The LIMS Business Analyst will be the face of the LabWare Laboratory Information Management System  (LIMS)\Electronic Laboratory Notebook (ELN) at the Charles City Facility, by acting as the first level support contact for operational support and Master Data builds. They will configure, support, maintain and administer the LabWare LIMS\Electronic Laboratory Notebook (ELN) Master Data at the Charles City Facility, while collecting and maintaining requirements for the facility for process workflows. They will work with a development team to validate and deploy updated processes.

• Configure and maintain LIMS Master Data to support inventory management, QC\Analytical Research workflows, Raw Material\Intermediate\Finished API testing and release, ELN, cleaning validation and integration with other computerized site systems and instruments.
• Provide sound technical subject matter expertise on local and multi-site LIMS Master Data and workflows.
• Coordinate LIMS\ELN requirements gathering, fit-gapping, issue root cause identification, solution demos, validation testing, and documentation requirements for the site.
• Schedule business meetings and manage escalations to LIMS Development group, by applying impact assessments of the current issue list for the facility in order to support prioritization
• Assist with writing and execution of test scripts for validating LIMS\ELN workflows while maintaining cGDP principles
• Generate Master Data Verification Paperwork and manage the Master Data process from requirements induction to Production Promotion and Approval for use.
• Ability to interpret scientific documents, e.g. specifications and test methods, into LIMS coding to produce the required outcome in the system
• Primary contact for users to troubleshoot LIMS\ELN issues. Ability to evaluate and escalate as required.
• LIMS\ELN primary trainer for site personnel. Creates\updates user accounts following site procedures.

• Implement CAPAs to address LIMS\ELN related corrections and ensure CAPAs are completed within assigned time frame.
• Write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.
• Understanding of pharmaceutical regulatory requirements cGDP and cGMP
• Able to communicate timelines, issues blocking progress, and status updates to management.

• Bachelors or Master's Degree in life science or computer science/IT.

• 3+ years of experience preferred in configuration and administration of Laboratory Information Management Systems (LIMS).

• Experience supporting and integrating lab applications in a regulated industry.

• Experience with 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.

• Knowledge of cGMP manufacturing.

PI288164427