Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents
Job Summary
Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents.
Support optimization and maintenance of the DMS process, including updates to the procedure, the system (CDOCS), and associated training materials.
Create, update, and deliver training materials for document owners, reviewers, and approvers on good Quality writing per our document hierarchy and document authoring standards.
Matching Summary
Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents.
Skills & Requirements
Must-have
Technical writing and editing expertise
DMS process optimization and maintenance
CDOCS system and training materials
Document authoring standards
GMP regulations experience
Nice-to-have
Exceptional attention to detail
Proactive in a fast-paced environment
Knowledge management across Quality operations
Critical thinking and problem-solving
Key Requirements
Master's degree and 8-10 years experience OR Bachelor's degree and 10-12 years experience
Pharmaceutical/Biotechnology Quality, R&D, or Manufacturing experience
Prior technical writing experience in a regulated space