Technical Writer - 9118
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.
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).
- 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
- 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.