Description

The LIMS Business Analyst / Administrator is responsible for configuring, maintaining, and supporting the LIMS system to enable laboratory operations. This role builds and maintains Master Data, provides training and day‑to‑day user support, and collaborates with cross‑functional teams to implement improvements. The individual will serve as the site liaison to the technical LIMS team and translate laboratory workflows into LIMS processes. The role ensures the system supports compliant, efficient, and accurate data management for pharmaceutical operations.

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, stability program management and systems integration.
• Provide subject matter expertise on local and multi-site LIMS projects.
• Ensure system compliance with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
• Build and maintain static and variable master data within LIMS.
• Write and execute validation protocol test scripts, including validation of LIMS subroutines, analyses and other code-based functionality.
• Serve as primary contact for troubleshooting LIMS issues and work to resolve in a timely manner. Collaborates with IT, the LIMS Vendor, and System Administrators to troubleshoot / resolve application and end-user issues.
• Implement and manage Change Controls and CAPAs to address LIMS related corrections and ensure changes or CAPAs are completed within assigned time frame.
• Develop and maintain LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.
• Maintain critical data and metadata within LIMS (including but not limited to specifications, protocols, test methods, storage locations, equipment, utility testing schedules, and stability protocols), aka Master Data.
• Identify workflow gaps and implement solutions to improve efficiency.  
• Provide LIMS training to site personnel and support training efforts at other company locations as needed.
• As needed, provide coverage of Master Data building and end-user support for other company sites.

• Experience supporting and integrating lab applications in a regulated industry.
• Knowledge of 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.
• Strong understanding of LIMS and computer systems.
• Strong software troubleshooting experience.
• Strong understanding of laboratory processes, ideally in a FDA-regulated Pharma environment.

• Bachelor's or Master's Degree in Life Sciences, Computer Science, or a related field.
• 3+ years of experience configuring and administering Laboratory Information Management Systems (LIMS).

Preferred Qualifications:

• 3+ years of laboratory experience in a GMP environment
• Experience building LIMS Master Data

PI282637976