MSAT Documentation Scientist II
Core
Develops and maintains GMP documentation, coordinates training programs, and drives continuous improvement in a regulated pharmaceutical manufacturing environment.
Role type
Mid-level documentation scientist (pharmaceutical manufacturing)
Builds
GMP-compliant documentation systems and training strategies for sterile manufacturing operations
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, technical writing, process design evaluation, CAPA investigation leadership, cross-functional liaison, project timeline management, regulatory compliance maintenance
Preferred skills
Pharmaceutical industry experience, pre-clinical/clinical/post-marketing drug development knowledge, change control management
Technologies
Electronic Quality Management Systems, Document Management Systems, Microsoft Office Suite
Responsibilities
Author and improve SOPs, Batch Records, Protocols, and training documents; Lead cross-functional investigation teams for CAPA closure; Present recommendations internally; Manage project timelines and deliverables; Liaise with Quality, Operations, Engineering, and Validation teams; Guide documentation strategies for new methodologies
Seniority
Junior to Mid-level, hands-on IC
