LIMS Administrator

• Configure and maintain the Fresenius Kabi LIMS computer system
• Establish and adhere to standard operating procedures and policies
• Support global validation and maintenance of the core system
• Maintain the LIMS and troubleshoot issues to ensure functionality
• Update and create product entries as needed
• Perform administrative functions such as account management
• Monitor network response times
• Support site validation for North America
• Coordinate cross-functional training and collaboration with Microbiology, QA, Chemistry, Stability, I&D, and IQC groups
• Ensure adherence to LIMS User Requirement Specifications and Design Qualification
• Participate in cGMP inspections and other audits as a company representative
• Coordinate document updates with USP, Product Specification, and MOA changes
• Develop, implement, and maintain LIMS Standard Operating Procedures
• Develop LIMS training modules and oversee end-user training
• Assist other Fresenius Kabi sites with implementation efforts
• Act as the site contact for the FK Global LIMS Administrator

• Bachelor of Science with minimum of 3 years of related experience preferred
• One-two years of pharmaceutical laboratory experience required
• Strong background in laboratory informatics and data systems
• Strong computer skills
• Excellent verbal and written communication skills
• Must effectively speak, read, write, and understand English
• Ability to independently understand policies, procedures, training materials, and workplace communications written in English

Demonstrates expertise in configuring and maintaining LIMS systems, ensuring compliance with cGMP standards, and facilitating cross-functional collaboration. Proficient in developing standard operating procedures and training modules to enhance laboratory informatics and data management.

• LIMS Configuration and Maintenance
• Laboratory Informatics
• CGMP Compliance
• Cross-Functional Collaboration
• Training Module Development

• LIMS Administration
• Data Systems Management
• Standard Operating Procedures Development
• Troubleshooting
• Account Management
• Document Coordination
• Validation Support
• Product Entry Management
• Network Monitoring
• Pharmaceutical Laboratory Experience

• Excellent Communication Skills
• Team Collaboration
• Independent Understanding

• CGMP Inspections
• User Requirement Specifications
• Design Qualification
• Microbiology
• Quality Assurance
• Chemistry
• Stability
• I&D
• IQC

• Fresenius Kabi LIMS