LIMS Administrator

Fresenius Kabi USA•Grand Island, NY

21h•$60,966 - $85,694•Onsite

About The Position

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.

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.

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
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
All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities