Technical Writer Job at SGS Consulting, Pennsylvania

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  • SGS Consulting
  • Pennsylvania

Job Description

Job 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 lab activities, on an as needed basis.

Skills:

  • Proficiency in Scientific Writing/Technical Writing,
  • Experience in Empower chromatographic data system,
  • Experience with LIMS, SAP/SRM, Track Wise, and Veeva,
  • Experience in GMP/GLP and/or a regulated industry.

Education/Experience:

  • 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, 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.
  • BS in Chemistry, Biology or a related scientific discipline.

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