Technical Writer - 9118

Location: Summit, New Jersey, United States
Salary: competitive
Job Type: Contract
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Job Title: Technical Writer

Location: On-site in Summit, NJ

Duration: 6 month contract with possibility of extension due to performance

Compensation: Varies depending on experience

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

Description:

The Technical 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).

Primary Role:

  • Author and revise documents as needed including deviations, CAPA's (Corrective And Preventative Actions) 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

Experience:

  • Bachelor's Degree required, preferably in Science - 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 direct experience in 'written' deviations, not just 'reviewing' deviations
  • Proven working experience in writing GMP documents/ GMP documentation systems
  • Performs and documents in writing investigation of manufacturing deviations and events utilizing root cause analysis techniques.
  • Experience in deviations/investigations and determining root cause
  • 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)
  • Strong working knowledge of Microsoft Office

Sthree US is acting as an Employment Business in relation to this vacancy.

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