MSAT Process Technical Writer
Core
Create, edit, and manage manufacturing batch records and cGMP documentation to support production operations, product quality, and regulatory compliance.
Role type
Process Technical Writer
Builds
Manufacturing batch records and cGMP documentation
Domain
Life sciences / Pharmaceutical manufacturing
Required skills
cGMP documentation, batch record creation, document revision management, regulatory compliance, document review coordination, stakeholder feedback translation, documentation scheduling, risk escalation, cross-functional collaboration, Microsoft Word proficiency, project management
Preferred skills
Biotechnology or Life Sciences background, pharmaceutical/biotech industry experience, technical writing in cGMP environment
Technologies
Microsoft Word, document management systems
Responsibilities
Create and format process batch records and cGMP documentation; Manage document revisions including scope reviews and approvals; Facilitate document review meetings; Translate stakeholder feedback into compliant documentation updates; Maintain documentation schedules for manufacturing campaigns; Communicate document status and escalate risks; Partner with subject matter experts to meet regulatory and business requirements
Seniority
Individual Contributor
