Edison-New Brunswick Metro Area, NJ
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.