Create and edit batch records (the instructions for production of bulk drug substance) in Microsoft Word.
Meet with engineers to gain an understanding of how the process will be run at manufacturing scale and draft the batch records using a template as a starting point.
Incorporate comments as needed during record review and route the document for review through a documentation management system.
Creation of the batch records will require close collaboration with technical project leads, operations staff, and quality assurance.
Secondary job responsibility will be revision of manufacturing procedures.
Job Description
Qualifications
Technical Writer needs 5 years experience
Technical Writer requires:
technical writing
Technical Writer duties:
The primary job responsibility will be creating and editing batch records (the instructions for production of bulk drug substance) in Microsoft word.
The writer will meet with engineers to gain an understanding of how the process will be run at manufacturing scale and will then draft the batch records using a template as a starting point.
The writer will then incorporate comments as needed during record review and route the document for review through a documentation management system.
Creation of the batch records will require close collaboration with technical project leads, operations staff, and quality assurance.
The secondary job responsibility will be revision of manufacturing procedures.