Senior NPI Systems & Quality Risk Associate - Remote

Amgen; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

Bonus potential

Stock options

Flexible work options

Company shutdowns

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant is hiring a Senior Associate Manufacturing – New Product Introduction Systems. The role focuses on coordinating cross‑functional activities to enable compliant, timely NPI implementation, with emphasis on QRAs, BOMs, and Change Controls.

The position requires GMP manufacturing experience, strong documentation skills, and the ability to manage multiple priorities while delivering on timelines.

Qualifications

• Experience in GMP manufacturing or manufacturing support.
• Experience facilitating cross-functional QRAs, FMEAs, or risk-management activities.
• Experience using Quality Management Systems for Change Controls and CAPAs.

Responsibilities

• Facilitate cross‑functional QRAs and coordinate risk discussions.
• Create and maintain QRA reports, FMEAs, and risk action logs.
• Create and maintain process BOMs and coordinate material readiness.
• Coordinate BOM inputs across Supply Chain, MES, SUS, Manufacturing and other teams.
• Own NPI Change Control records and manage lifecycle documentation.
• Track pre-, during-, and post-implementation tasks and ensure evidence and traceability.
• Maintain trackers and provide status updates to NPI management.
• Build strong cross-functional relationships and communicate complex issues clearly.

Skills

Cross-functional coordination

Meeting facilitation

Technical writing

Quality systems

GMP manufacturing

Education

Master’s degree

Bachelor’s degree + 4 years experience

Associate’s degree + 8 years experience

High school diploma / GED + 10 years experience

Tools

Veeva QMS

TrackWise

MES

Electronic Batch Records

Job description

Amgen North Carolina Biologics Drug Substance Manufacturing plant is hiring a Senior Associate Manufacturing – New Product Introduction Systems. The role focuses on coordinating cross‑functional activities to enable compliant, timely NPI implementation, with emphasis on QRAs, BOMs, and Change Controls.

The position requires GMP manufacturing experience, strong documentation skills, and the ability to manage multiple priorities while delivering on timelines.