Manufacturing Senior Associate
Core
Author, revise, and manage the lifecycle of controlled GMP documents (SOPs, forms, protocols, reports) to ensure compliance and operational effectiveness in manufacturing.
Role type
Senior IC manufacturing documentation specialist
Builds
Controlled GMP documentation and standardized processes for manufacturing operations
Domain
Biopharmaceutical manufacturing / Quality Systems
Required skills
GMP/cGMP compliance, technical writing, document lifecycle management, cross-functional coordination, project management, metrics analysis, process improvement, electronic document management systems (EDMS)
Preferred skills
GMP-regulated environment experience, SOP authoring, stakeholder facilitation, continuous improvement leadership
Technologies
Veeva, CDOCS, EDMS, TrackWise
Responsibilities
Author and revise controlled GMP documents; coordinate cross-functional document reviews and revisions; manage document revision schedules and track progress; generate documentation performance metrics; support audit and inspection readiness; drive continuous improvement in documentation processes
Seniority
Senior, hands-on IC
