Technical Writer, QC Incoming
Newark Metro Area, NJ
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.
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
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