Job Description
SUMMARY/OBJECTIVE:
The Technical Writer, Analytical is responsible for supporting and coordinating Quality Management System (QMS) documentation activities for the laboratory and Analytical functions. This role will partner closely with laboratory personnel and Quality Assurance to draft, revise, route, and maintain compliant GMP laboratory documentation supporting analytical testing and development activities. This individual will serve as a key liaison between Analytical R&D and Quality Assurance for laboratory quality documentation and related quality system activities. The role requires strong technical writing capabilities, scientific comprehension, and familiarity with GMP laboratory documentation practices in a regulated pharmaceutical or CDMO environment.
ESSENTIAL DUTIESAND RESPONSIBILITIES:
- Drafts, revises, formats, and coordinates controlled laboratory documentation including:
- SOPs
- Test methods
- Specifications...