Strong technical writing skills in regulated environment
Working knowledge of cgmp regulations for quality control
Microbiology and environmental monitoring experience
This role supports Amgen's global Quality Control network by managing the end-to-end lifecycle of controlled documents for microbiology and environmental monitoring
Job Summary
This role supports Amgen's global Quality Control network by managing the end-to-end lifecycle of controlled documents for microbiology and environmental monitoring.
The position requires collaboration with cross-functional partners across multiple time zones to ensure process harmonization and regulatory compliance.
Candidates will gain broad exposure to Amgen's diverse product portfolio while driving continuous improvement in document structure and data retrieval practices.
Matching Summary
This role supports Amgen's global Quality Control network by managing the end-to-end lifecycle of controlled documents for microbiology and environmental monitoring.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Strong technical writing skills in regulated environment
Working knowledge of cGMP regulations for Quality Control
Microbiology and Environmental Monitoring experience
Experience with LIMS and electronic laboratory notebooks
Shift-based schedule availability including remote support
Nice-to-have
Innovative thinking to transform work processes
Exposure to Operational Excellence initiatives
Understanding of drug substance and product QC processes
Ability to navigate ambiguity and structured problem solving