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Urgent! Technical Writer Position in Exton - Katalyst HealthCares & Life Sciences

Technical Writer



Job description


Responsibilities:

  • 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 - 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, Track Wise, 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.




  • Required Skill Profession

    Media And Communication Workers



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