- Write, create, draft, edit, review and maintain documents designed to explain and test laboratory systems.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Creates and maintains technical writing standards.
- Writes, modifies/changes controlled documents.
- Writes, reviews, and maintains department standard operating procedures.
- Edit, standardize, or make changes to materials prepared by other writers or personnel.
- Coordinates projects and documentation assignments.
- BS/BA degree required
- 5+ years of experience with bio pharmaceutical equipment or manufacturing, particularly in Quality Review required
- Good documentation practices (GDP)
- FDA regulated environments
- Laboratory systems
- Nonconformance and deviation management
- Building consensus among subject matter experts
- Process mapping
- Harmonizing documentation across groups
- Document control including document management systems