Analytical Technical Writer Job at Joulé in Exton

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• Author technical reports, policies, and Standard Operating Procedures.
  
• Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
  
• Author investigations, deviations, change controls, and other non-conformance records.
  
• Work with vendors to coordinate testing and arrange shipments as needed.
  
• Compile and review scientific data for completeness as needed.
  
• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
  
• Use of LIMS database including protocol setup, data entry/approval, and data trending.
  
• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
  
• Coordinate document review, approval, and archiving.
  
• Participate in analytical testing lab activities, on an as needed basis.
  
  
  
  Requirements
  
  
  
  
  • BS in Chemistry, Biology or a related scientific discipline.
    
  • At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
    
  • Proficient in scientific/technical writing.
    
    
    
    
    
    • Experience in Empower chromatographic data system
      
    • Experience with LIMS, SAP/SRM, TrackWise, and Veeva.
      
    • Excellent oral communication, interpersonal and technical writing skills.
      
    • Excellent organizational skills, demonstrate attention to detail.
      
    • Experience in GMP/GLP and/or a regulated industry.
      
    • Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
      
    • Advanced Excel knowledge is a plus.
      
      
      
      
      
      Benefits
      
      System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
      
      
      
      
      
      Ref: #558-Scientific

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