LIMS Administrator

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

401k contributions

Paid vacation

Holiday & personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA's Melrose Park facility seeks a LIMS Administrator to configure and maintain the LIMS across production units. You will collaborate with Quality Control labs and QA to ensure GLP and GMP compliance and accurate data management.

The role involves SOP development, training end-users, validation support, and cross-functional collaboration with Microbiology, Chemistry, and IQC teams, while representing the site in audits. A BS with 3+ years pharma experience is required.

Qualifications

• Bachelor of Science with at least 3 years of related experience.
• 1–2 years of pharmaceutical laboratory experience required.
• Strong background in informatics and data systems.
• Excellent verbal and written communication in English.

Responsibilities

• Configure and maintain the LIMS at Fresenius Kabi production units.
• Establish and adhere to standard operating procedures and policies.
• Support Global validation and maintenance of the core system.
• Troubleshoot issues and ensure functionality of the LIMS.
• Coordinate document updates with USP and MOA changes.
• Develop, implement, and maintain SOPs for the LIMS.
• Oversee training of system end-users.
• Represent the site in cGMP inspections and audits.

Skills

Laboratory informatics

Data systems

Strong computer skills

Excellent communication

Verbal and written communication

Documentation

Education

Bachelor of Science

Tools

LIMS

Laboratory data systems

Job description

Job Summary

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
Salary Range: $75,000-95,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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
• 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, andwellness 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.