LIMS Business Analyst

Cambrex•Charles City, IA

About The Position

The LIMS Business Analyst serves as the primary site contact for operational support and Master Data builds for the LabWare Laboratory Information Management System (LIMS) and Electronic Laboratory Notebook (ELN) at Cambrex’s Charles City Facility. The role configures, supports, maintains, and administers LIMS/ELN Master Data, collects and maintains process workflow requirements, and works with a development team to validate and deploy updated processes. The role provides technical expertise and user support for local and multi-site LIMS Master Data and workflows. It coordinates requirements gathering, fit-gap analysis, issue investigation, solution demonstrations, validation testing, and documentation. The analyst also supports system training, regulatory compliance, and the preparation and maintenance of system documentation.

Requirements

Bachelor’s or master’s degree in life science or computer science/IT.
Experience supporting and integrating laboratory applications in a regulated industry.
Experience with 21 CFR Part 11, data integrity best practices, and computerized system regulatory compliance.
Knowledge of cGMP manufacturing.
Understanding of pharmaceutical cGDP and cGMP requirements.

Nice To Haves

Three or more years of experience in configuration and administration of Laboratory Information Management Systems (LIMS) is preferred.

Responsibilities

Configure and maintain LIMS Master Data for inventory management, QC/Analytical Research workflows, raw material, intermediate, and finished API testing and release, ELN, cleaning validation, and integrations with site systems and instruments.
Provide technical subject matter expertise on local and multi-site LIMS Master Data and workflows.
Coordinate LIMS/ELN requirements gathering, fit-gap analysis, root-cause identification, solution demonstrations, validation testing, and site documentation requirements.
Schedule business meetings and manage escalations to the LIMS Development group, using facility issue impact assessments to support prioritization.
Assist with writing and executing validation test scripts for LIMS/ELN workflows while maintaining cGDP principles.
Generate Master Data Verification Paperwork and manage the Master Data process from requirements induction through Production Promotion and approval for use.
Interpret scientific documents, such as specifications and test methods, into LIMS coding to achieve required system outcomes.
Serve as the primary user contact for troubleshooting LIMS/ELN issues, evaluating issues and escalating them as appropriate.
Provide primary LIMS/ELN training for site personnel and create or update user accounts following site procedures.
Implement CAPAs for LIMS/ELN-related corrections and ensure they are completed within assigned time frames.
Write and update LIMS-related SOPs, work instructions, protocols, and other system-specific documentation.
Communicate timelines, blockers, issues, and status updates to management.