Job Description
Scope
The Technical Writer will provide an important role in the support of GMP manufacturing processes by creating and revising Technical documents including Master Batch Records, Standard Operating Procedures, Protocols, Reports, Specifications, and other Technical Documents. In addition, the technical writer will provide training/assistance to other Scientific Technical Writers and Engineers related to writing Technical documents or using Microsoft Word.
Responsibilities
Prepare/Revise Master Batch Records, Standard Operation Procedures, Protocols, Reports and Specifications for use in GMP manufacturing/packaging. Prepare/revise other Technical documents (e.g. Campaign Summary Reports, Risk Assessments). Meet with internal or external customers to align on and revise technical documents and procedures. Provide training and technical expertise to other Writers and Engineers. Other duties as assigned Education.
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Experience
Bachelor's degree in a scientific field, preferably biology or chemistry.
3-5 years of experience in the preparation of technical documents, preferably technical writing GMP experience preferred Experience in managing priorities and schedule.
Knowledge, Skills, Abilities
Understanding of Regulatory requirements include USP/NF and Ph. Eur preferred Advanced level skills with Microsoft Word, Excel and PowerPoint.
Excellent communication skills in English, both written and spoken Excellent attention to detail.
Self-motivated and able to work independently