Tech Writer - SOPs, Quality
Edison-New Brunswick Metro Area, NJ
- BS in Scientific Discipline. 2 - 5 years of technical writing experience in pharmaceutical including 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.
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.