NPI Systems & Change Control Specialist (Remote)

BioSpace; Holly Springs (NC); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement and savings plan

Medical, dental, vision coverage

Stock-based incentives

Generous time-off plans

Job summary

Amgen North Carolina’s Biologics Drug Substance Manufacturing plant seeks a Senior Associate Manufacturing - New Product Introduction Systems. You will support NPI programs by coordinating cross-functional activities, managing QRAs, BOMs, and Change Controls, and ensuring compliant documentation across Manufacturing, Quality, and Process Development.

The role emphasizes risk assessment, project coordination, and timely execution, with opportunities to contribute to continuous improvement and

Qualifications

• Masters degree or equivalent in Manufacturing/Operations.
• Bachelors degree with 4+ years Manufacturing/Operations experience or equivalente.
• Associate's degree with 8+ years Manufacturing/Operations experience.
• High school diploma/GED with 10+ years Manufacturing/Operations experience.

Responsibilities

• Coordinate cross-functional QRAs, document decisions and approvals.
• Prepare and maintain QRA reports, FMEA, risk logs, and related records.
• Create and maintain process Bills of Materials (BOMs).
• Coordinate BOM inputs across Supply Chain, MES, SUS, and Manufacturing.
• Own Change Control records; manage assessments and implementation planning.
• Track tasks and dependencies; ensure evidence and traceability.
• Maintain trackers and provide status updates to NPI management.
• Build relationships across functions and communicate clearly.

Skills

Cross-functional coordination

Quality risk assessments

Technical writing

Change controls

Documentation

Education

Master's degree in manufacturing/engineering

Bachelor's degree + 4 years exp

Associate's degree + 8 yrs exp

High school diploma + 10 yrs exp

Tools

Veeva QMS

TrackWise

MES

SUS

Job description

Amgen North Carolina’s Biologics Drug Substance Manufacturing plant seeks a Senior Associate Manufacturing - New Product Introduction Systems. You will support NPI programs by coordinating cross-functional activities, managing QRAs, BOMs, and Change Controls, and ensuring compliant documentation across Manufacturing, Quality, and Process Development.

The role emphasizes risk assessment, project coordination, and timely execution, with opportunities to contribute to continuous improvement and