• 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 system