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Reference # : 18-01372 Title : Technical Writer
Location : Morris Plains, NJ
Experience Level : Start Date / End Date : 06/04/2018 / 12/07/2018  
Description
Author, update, consolidate and review SOPs, work instructions, forms, templates and logbooks in accordance with compliance management oversite and strategy. Present authorship strategy to Quality Compliance & QMS to get pre-approval and endorsement. Other writing tasks as applicable. May be required to support continuous improvement activities and database establishment.

Ability to author technical instructions independently and in accordance with all governing SOPs/GOPs
Exceptional ability to proof read and quality check controlled cGMP documents
Mastery of Microsoft Word and proficiency in Excel
Knowledge of cGMP compliance requirements from a document perspective
Interact with compliance and QMS associates with multiple levels of experience in order to determine and rectify any issues/gaps within current procedures.
Ability to observe processes and translate into written instruction; identify and close gaps
Demonstrate capacity to handle creation/revision of multiple documents and facilitate timely progress through the document lifecycle cycle.

(Technical) University/academy degree in biological sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.
2 - 5 years of pharmaceutical/biotechnology experience in Quality Compliance, Quality Management Systems, and/or Quality Assurance.