Job Details

  • Title: Technical Writer
  • Code: RCI-8848
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 12/02/2019
  • Duration: 6 Months
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  Job Description


1. Purpose and Scope of Position

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).

2. Required Competencies: Knowledge, Skills, and Abilities

  • Proven working experience in writing GMP documents
  • Ability to deliver high quality documentation paying attention to detail
  • 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
3. Duties and Responsibilities
  • Author and revise GMP documents
  • Author and revise documents as needed
  • 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
4. Education and Experience
  • Bachelor’s Degree required, preferable in Science
  • At least 5-8 years of relevant work experience, preferable in a regulated environment
  • An equivalent combination of education and experience may substitute
5. Working Conditions
  • The incumbent will work 40 hours a week, including some weekends and holidays