JOB: Technical Writer, Canada and USA JOB DESCRIPTION • Create new or revise existing content for SOPs and validation documents with a high degree of quality in accordance with cGMP requirements and corporate guidelines • Write IQ/OQ/PQ and commissioning documents • Work collaboratively with a project team members including manufacturing, engineering, process development, quality and other subject matter experts to solidify content • Composing product quality compliant handling documentation including but not limited to Standard • Operating Procedures (SOPs), work instructions and training materials • Reading existing documentation and other material to become familiar with current and desired future state processes • Adhering to Good Documentation Practices (GDPs) • Some independent work will be necessary to gather information via interviewing/interacting with • Quality System Element (QSE) personnel to author documents • Assuring authored documents are in compliance with documentation control and training requirement • May be required to perform other duties and responsibilities as requested QUALIFICATIONS • Bachelor’s Degree-Preferably in a Scientific or technical Field • Junior (2-7 years) of related experience in technical writing • Technical writing experience in an FDA regulated industry environment required-preferably in biotechnology industry • Must have prior experience authoring GMP documents such as SOPs, and validation documents, etc., • Knowledge of GDP is also required • Great attention to detail and the ability to communicate well with others is required • Exceptional written and verbal communication skills • Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation • Skilled at organizing information into a clear and concise written form • Ability to multi-task and work in a deadline-driven environment • Ability to work independently as well as in a team environment • Good command of MS Office Suite (word,...
Posted on: Wed, 03 Jul 2013 21:07:16 +0000
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