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Technical Writer
Ref No.: 19-16478
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Technical Writer in Summit, NJ with one of our top client.
Job Title: Technical Writer
Job Id: 19-16478
Location: Summit, NJ 07901
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Description
  • 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).
Required Competencies
  • 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 system
  • Good organizational skills and critical thinking skills
  • Excellent written skills in English
  • Strong working knowledge of Microsoft Office
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 thedocumentation 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
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
Working Conditions
  • The incumbent will work 40 hours a week, including some weekends and holidays
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
  • The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position
  •  There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
  • Employees holding this position will be required to perform any other job-related duties as requested by management. 
Contact
Sunny Rajput
Direct: (732) 272 0302 | Email: Sunny.R@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com