LIMS Specialist (pharma) Job at Insight Global, Wilson, NC

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  • Insight Global
  • Wilson, NC

Job Description

Must Haves:

  • Bachelor's Degree in STEM or related field
  • 4-6 years of working experience in a pharmaceutical environment
  • Experience with LIMS and Quality Systems
  • Extensive other experience with analytical testing, quality control or IT
  • Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
  • Ability to interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories

Job Description:

Insight Global is seeking a LIMS Specialist for a large client in the Wilson, NC area. This position works within the eLIMS CoE and is an expert in data setups in the eLIMS system to support lab processes including paperless, product release and CofA generations. Additionally, this position will support an implementation of the LIMS LabVantage (eLIMS) system at a new plant based in North Carolina. This position independently maintains and reviews high quality data setups, integrates instruments and applications and translates specifications within the eLIMS system using current business processes. This position reviews and tests system updates, creates and manages any system related documents, and identifies and drives process improvements. This position is able to interact with IT and speaks business language to customers.This position takes ownership by completing any incoming requests in a timely manner. In order to maintain high quality data. This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.

Responsibilities:

  • Lead projects within QC Operations, e.g. implementation of paperless processes, harmonization / standardization of processes.
  • Work with multiple stakeholders to provide input and ensure end to end set up of eLIMS master data to support implementation.
  • Maintain system related documentation (procedures, events, etc) with the appropriate applications (TruVault, COMET, Confluence, q-Test or any other designed system

Job Tags

Work experience placement, Local area,

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