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Technical Writer - Pharma
Ref No.: 20-00529
Location: Summit, New Jersey
Job Description:
  • The Tech writer for CAR T Systems and services works independently and is responsible for authoring high-quality documentation in support of GMP manufacturing.
  • This includes but is not limited to deviation investigations, CAPA's, SOP's and Work Practices (Equipment, personnel, manufacturing and batch records).
  • Author and revise GMP documents.
    • Author and revise documents as needed including deviations, CAPA's and change controls.
    • Manage the development of documents through the document management system.
    • Assist in executing change controls where needed.
    • Work with internal teams to obtain an in-depth understanding of the process and the documentation requirements.
    • Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.
    • Write easy-to-understand instructions where required.
    • Create tutorials to help end-users train on a variety of activities.
    • Create and maintain documentation projects and timelines.
    • Provide excellent attention to detail in writings.
    • Apply critical thinking skills when working out new procedures.
  • Performs other tasks as assigned.

Qualifications:
  • ** DO NOT SUBMIT candidates with R&D-ONLY environment background, must have experience in GMP environment [manufacturing or QA preferred]
  • Bachelor's Degree required, preferable in Science [No PhD's] -- An equivalent combination of education and experience may substitute.
  • At least 5-8 years of relevant work experience, preferable in a GMP regulated environment.
  • Must have experience in 'written' deviations, not just 'reviewing' deviations.
  • MUST HAVE:
    • Direct experience with writing deviations/investigation.
    • GMP (and preferred QA experience).
    • Must be able to work independently and as a team.
  • Proven working experience in writing GMP documents.
  • Performs and documents in writing investigation of manufacturing deviations and events utilizing root cause analysis techniques.
  • Experience in deviations/investigations and determining root cause
  • Problem solving
  • Writes, reviews, and maintains department standard operating procedures
  • Ability to deliver high quality documentation paying attention to detail under accelerated timelines.
  • Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
  • Ability to work in a highly regulated environment, following Good Documentation Practices (GDPs).
  • Advanced ability to work in a collaborative team environment and train others.
  • Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.
  • Ability to set priorities.
  • Familiar with GMP documentation systems.
  • Good organizational skills and critical thinking skills.
  • Excellent written skills in English.
  • Strong working knowledge of Microsoft Office

Working Conditions:
  • The incumbent will work 40 hours a week, including some weekends and holidays
  • IMPORTANT: Pertaining to performance, manager will offer only one warning and no improvement will mean release of contractor.