Job Summary

Responsibilities

The Laboratory Information Management System (LIMS) Administrator is responsible for configuration and ongoing maintenance of the LIMS at the Fresenius Kabi production units.  This position reports to the LIMS Manager or Supervisor and is responsible for directly supporting production units and other levels of the organization.  The LIMS administrator ensures that the LIMS meets the requirements of Fresenius Kabi LIMS procedures.  The LIMS Administrator works closely with the various Quality Control laboratories and Quality Assurance to ensure compliance with GLP and GMP requirements.

Job Responsibilities:

• Responsible for the configuration and maintenance of the Fresenius Kabi LIMS computer system
• Responsible for establishing and adhering to standard operating procedures and policies
• Supports Global validation and maintenance of the core system
• Maintains the LIMS

• Troubleshoot issues and ensure functionality of the LIMS system
• Updates and creates product entries as needed
• Performs administrative functions, such as account management
• Monitors network response times

• Supports the Site Validation for North America
• Cross functional training and collaboration with Microbiology, QA, Chemistry, Stability, I & D, IQC groups for rolling out additional LIMS modules and new functionality
• Ensures adherence to the LIMS User Requirement Specification and Design Qualification
• Represents the company with active participation in cGMP inspections and other audits.
• Follows through on their assigned tasks and ensure adherence to deadlines
• Coordinates document updates with USP, Product Specification and MOA changes
• Develops, implements, and maintains Standard Operating Procedures for the LIMS
• Develops training modules for training for use of the LIMS
• Oversees the training of the system end-users
• Assists other Fresenius Kabi sites with their implementation efforts
• Acts as the site contact person for the FK Global LIMS Administrator

Job Requirements:

• 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 are essential.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.