LIMS Specialist

The LIMS Specialist will configure, support, maintain and administer the LIMS database, collecting and storing data for pharmaceutical commercial operations. The position will interpret needs of the business through analysis to create LIMS set up needs.

• Configure and maintain LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation and integration with other computerized site systems.
• Provide sound technical subject matter expertise on local and multi-site LIMS projects.
• Configure static and master data within LIMS.
• Conduct validation of LIMS subroutines, analyses and other code-based functionality.
• Assist with writing and execution of test scripts.
• Primary contact for users to troubleshoot LIMS issues.
• LIMS trainer for site personnel.
• Ensure system is compliant with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
• Implement CAPAs to address LIMS related corrections and ensure CAPAs are completed within assigned time frame.
• Write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.

• Knowledge of cGMP manufacturing

• 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.

PI281801820