Notes GMP documents , controlled documents documentation, revise batch records, record data, clear and accurate documentation revise master batch records, revise procedures will be given the content and need to edit, reformat, revise, etc.
then route for approvals, follow up where needed professionalism, team player, interact with other teams quick thinker take old records and revise using templates to newest format hard stop at 40 hours
6 months with possibility to extend based off business needs proactive, organized, prioritize be able to speak to changes, explain changes,answer questions Job Description:
The primary job responsibility will be editing master batch records (the instructions for production of bulk drug substance and associated solutions) in Microsoft Word to prepare for upcoming manufacturing campaigns. In addition to editing documents, the writer is responsible to route documents for review through a documentation management system. Collaboration is expected with technical project leads, quality engineers, and quality assurance. Education or experience in biotech field and/or working with GMP documents is highly desirable What is the minimum education experience required?: