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Technical Writer

Newark Metro Area, NJ

Job Type: Scientific Job Number: JN -122019-26060 Region: Newark Metro Area

Job 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: 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

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

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