LIMS Master Data Coordinator

Catalent

8d•Onsite

About The Position

The LIMS Master Data Coordinator will be responsible for the creation and revision, as well as review and approval of master data within the LabVantage® Laboratory Information Management System (LIMS) implemented at the Catalent Greenville site. This position will be responsible for providing end-user support for all analytical groups as well as compliance to global Catalent and internal policies and procedures. Additionally, the LIMS Master Data Builder may be tasked to participate in a global process for general or Catalent Global applicable master data creation, revision, and review. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

Requirements

Associate/bachelor’s degree in computer science, Life Sciences, Engineering, another STEM-related field is required.
At least 2 years of experience in the pharmaceutical industry or relevant laboratory experience in a related industry is required. Knowledge of cGMP and other regulatory requirements relative to LIMS systems and software validation experience.
Experience with LIMS or a Material Management System (e.g., SLIM, IntelliLIMS, LabWare) is required.
Ability to work in a manufacturing environment. Ability to stand, walk, and sit for extended periods. Lift up to 25 lbs as needed.

Nice To Haves

LabVantage experience preferred.
Hands-on experience with GROOVY or Java scripting to configure and optimize ELN/LES method workflows, including calculation logic and automated data handling preferred.

Responsibilities

Support QC, AR&D departments in the build and/or revision, review and approval of master data, including but not limited to products, specifications, and methods in LIMS, per global and local LIMS procedure
First-line support for end-user LIMS template and data entry issues
Assist in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing of master data
Assist in the development and implementation of a site process for the scheduling and status tracking of all site LIMS Master Data, including testing needs for Raw Material, Finished Goods, Stability, and other needed areas
Work with the site LIMS Supervisor to maintain site and Catalent Global requirements of LIMS.
Participate in the development and/or revision of site and/or Catalent Global Standard Operating Procedures (SOPs)
Develop, validate, and maintain Electronic Laboratory Notebook (ELN) and Laboratory Execution System (LES) methods, including implementation of automated calculations using GROOVY-based scripting.
Perform other duties as assigned.