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LIMS Specialist

  1. East Coast
Raleigh
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
12-04-2024
32592
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LIMS Specialist - Raleigh, US - 18-Months

Our client, a global Pharmaceutical manufacturing organization are looking for a talented LIMS Specialist  to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Responsibilities:
  • Leverage existing processes, procedures, and documents from other facilities where possible to provide an efficient CQV activities for the project
  • Assure suitability and/or cGMP compliance of equipment in quality control
  • Create and maintain project document QC approval plans and status updates

Requirements:
 
  • Setup complete LIMS Master Data including Analysis, Product Build and Static data
  • System administration and maintenance of LIMS (Labware LIMS v6)
  • User access administration, Label printer setup - optional
  • Analyze root causes of issues and provide appropriate resolutions based upon troubleshooting
  • Understanding of the ER (Entity Relationship) model – data structure of Labware LIMS to troubleshoot data issues
  • Experience in major Labware LIMS modules (i.e., Sample management, Inventory, Lot, Stability), and Instrument interfacing
  • Experience in Crystal reports development in LIMS (i.e., critical reports such as CofA, Analytical Reports)
  • Perform Change management including drafting IQ, OQ scripts along with defect management following GxP guidelines
  • Knowledge of the Pharmaceutical or Biotech industries
  • Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as CQV, QA, Engineering, Automation, and others
  • Be a team player who works well with colleagues and cross-functional teams
  • Be a self-starter and have a flexible, proactive, and dynamic approach to completion of work objectives and working with colleagues
  • Prior project or lab startup experience preferred

If this role is of interest to you, please apply now! 

 #LI-MC1
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