Job Title: Technical Writer
Location: Summit, NJ
Duration: 6 month contract
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: 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
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
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.
Sthree US is acting as an Employment Business in relation to this vacancy.