NPI Systems Specialist – Manufacturing Support

Amgen; Holly Springs (MS); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Flexible work models including remote

Job summary

Amgen is hiring for a Senior Associate Manufacturing - New Product Introduction Systems at our U.S. Biologics Drug Substance site.

You will support NPI programs by coordinating QRAs, FMEAs, BOMs, and change controls, interfacing with Manufacturing, Quality, Process Development and Supply Chain to ensure compliant, timely implementations. The role emphasizes quality documentation, lifecycle tracking, and cross-functional collaboration, with a focus on risk assessment, material readiness, and

Qualifications

• Master’s degree required or Bachelor’s degree with 4+ years Manufacturing/Operations experience
• Associate degree with 8+ years Manufacturing/Operations experience
• High school diploma or GED with 10+ years Manufacturing/Operations experience

Responsibilities

• Facilitate cross-functional Quality Risk Assessments (QRAs) and coordinate participants and documentation.
• Prepare and maintain QRA reports, FMEAs, risk action logs and related records.
• Create and maintain process Bills of Materials (BOMs).
• Coordinate BOM inputs across Supply Chain, MES, SUS, and Manufacturing.
• Own NPI Change Control records and manage lifecycle through approval.
• Track pre-, during, and post-implementation tasks and ensure traceability.
• Maintain trackers and provide status updates to NPI management.
• Build cross-functional relationships and communicate complex issues clearly.

Skills

Cross-functional coordination

Meeting facilitation

Technical writing

Quality-system skills

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

Job description

Amgen is hiring for a Senior Associate Manufacturing - New Product Introduction Systems at our U.S. Biologics Drug Substance site.

You will support NPI programs by coordinating QRAs, FMEAs, BOMs, and change controls, interfacing with Manufacturing, Quality, Process Development and Supply Chain to ensure compliant, timely implementations. The role emphasizes quality documentation, lifecycle tracking, and cross-functional collaboration, with a focus on risk assessment, material readiness, and