Description:

A primary focus of this role is creating and modifying LIMS test plans to support QC activities while adhering to regulatory and data integrity guidelines. The LIMS Coordinator is responsible for tracking and managing laboratory inventories within the LIMS system and to perform and verify daily verification of laboratory data for accuracy and completeness, ensuring compliance with GxP standards before submission for review.

Essential Functions:

• Register samples and input relevant test results, instrument data, and laboratory information into the LIMS system as per QC procedures.
• Manage laboratory inventories, ensuring timely replenishment and accurate record-keeping within the LIMS system as well as generate and run standard reports from the LIMS system for Laboratory Resource tracking.
• Perform and verify daily verification data for accuracy and completeness before submitting it for review.
• Create, troubleshoot and modify LIMS Test, worksheets, and test plans as needed to support QC activities.
• Train new peers in LIMS operations, including sample manager and resource modules.
• Assist QC personnel with sample registration and label generation using the LIMS software

Additional Responsibilities:

• Performs other functions as required or assigned.
• Hands on to follow compendial (USP/EP/BP/JP) procedures for wet chemical tests.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Follow up on sample status and testing progress within the LIMS system.
• Participate in continuous improvement initiatives to optimize LIMS functionality and workflows.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.