The Manufacturing Senior Associate is responsible for the authoring, revision, coordination, and lifecycle management of Manufacturing controlled documents. This role partners closely with Manufacturing, Quality, Process Development, Engineering, Validation, and other cross-functional stakeholders to ensure procedures and documentation remain accurate, compliant, effective, and inspection-ready.
- Author, revise, and maintain controlled GMP documents including SOPs, forms, protocols, reports, GDEs, work instructions, and training documents.
- Ensure documents comply with Good Documentation Practices (GDP), cGMP requirements, site procedures, and global standards.
- Perform periodic reviews of controlled documents and drive completion of updates.
- Review existing procedures for accuracy, consistency, and process alignment.
- Identify opportunities to improve document effectiveness, usability, and compliance.
- Nice to have: Experience in a GMP-regulated manufacturing environment
- Nice to have: Experience authoring and revising SOPs, protocols, reports, forms, and controlled documentation
- Nice to have: Experience using electronic document management systems (Veeva, CDOCS, EDMS, TrackWise)
- Nice to have: Experience generating and analyzing operational metrics
- Nice to have: Leading continuous improvement initiatives