|Reference # : ||18-01372
||Title : ||Technical Writer|
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.