LIMS Specialist

Cambrex•Charles City, IA

About The Position

The LIMS Specialist configures, supports, maintains, and administers the LIMS database used to collect and store data for pharmaceutical commercial operations. The role analyzes business needs and translates them into LIMS setup requirements. It supports QC testing, inventory management, raw material testing and release, cleaning validation, and integration with other computerized site systems. The specialist also provides technical expertise for local and multi-site projects, helps validate system functionality, supports users and trains site personnel, and maintains regulatory compliance and system documentation.

Requirements

Knowledge of cGMP manufacturing.
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.

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 modules for QC testing, inventory management, raw material testing and release, cleaning validation, and integration with other computerized site systems.
Provide technical subject matter expertise on local and multi-site LIMS projects.
Configure static and master data within LIMS.
Validate LIMS subroutines, analyses, and other code-based functionality.
Assist with writing and executing test scripts.
Serve as the primary contact for users troubleshooting LIMS issues.
Train site personnel on LIMS.
Ensure the system complies with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
Implement CAPAs for LIMS-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.