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Technical Writer, QC Incoming

Newark Metro Area, NJ

Posted: 11/07/2019 Job Type: Scientific Job Number: JN -112019-25942

Purpose and Scope of Position

The Technical Writer for the Quality Control (QC) Incoming group works independently and is responsible for authoring high-quality technical documentation in support of incoming material release. This includes, but is not limited to, material specifications, methods, justification of specifications, Standard Operating Procedures (SOPs), protocols and reports.

Required Competencies

Proven working experience in writing Good Manufacturing Practices (GMP) documents.

Ability to deliver a high volume of high-quality documentation, paying attention to detail.

Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.

Excellent written skills in English.

Strong working knowledge of Microsoft Office.

Ability to work in a highly regulated environment, following Good Documentation Practices (GDPs).

Ability to follow, review and revise SOPs.

Knowledge of analytical techniques such as HPLC, GC, FTIR, Osmolarity and pH.

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.

Familiar with GMP documentation systems.

Good organizational skills and critical thinking skills.

Education and Experience

Bachelor s Degree required, preferable in Science

Advanced Degree preferred

At least 4 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

The incumbent should be able to distinguish colors and possess correctable vision to 20/20

The incumbent may be doing light to moderate lifting and carrying objects under 15-20lbs

The incumbent may be working around biohazardous materials

The incumbent may be working in a warehouse setting for some part of the day

The incumbent may be exposed to fluctuating and/or extreme temperature on occasions

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