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Technical Writer

Edison-New Brunswick Metro Area, NJ

Posted: 05/16/2018 Job Type: Scientific Job Number: JN -052018-21594
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.

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