Senior Investigations Associate: Deviations & CAPA

Amgen SA; Holly Springs (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Stock-based incentives

Flexible work models

Paid time off and holidays

Job summary

Amgen is seeking a Senior Associate Manufacturing – Manufacturing Investigations in North Carolina. You will investigate major deviations in Biologics Drug Substance manufacturing, interfacing with Process Development, Facilities & Engineering, Automation, EHS, and Quality to drive improvements.

You will lead root cause analysis, develop CAPAs, and ensure compliant documentation, while presenting findings to regulators and auditors.

Qualifications

• Experience with deviation investigations in biologics/manufacturing.
• Ability to document and present findings clearly.
• Familiarity with environmental monitoring and contamination control.
• Experience communicating with multiple stakeholder groups.

Responsibilities

• Lead deviation and environmental monitoring investigations and root-cause analysis.
• Develop CAPAs and ensure compliant documentation.
• Present investigations to regulators and internal auditors.
• Coordinate cross-functional teams to meet milestones.
• Communicate progress to leadership and manage stakeholder expectations.

Skills

Strong communication

Cross-functional collaboration

Problem-solving

Project management

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

Veeva QMS

Job description

Amgen is seeking a Senior Associate Manufacturing – Manufacturing Investigations in North Carolina. You will investigate major deviations in Biologics Drug Substance manufacturing, interfacing with Process Development, Facilities & Engineering, Automation, EHS, and Quality to drive improvements.

You will lead root cause analysis, develop CAPAs, and ensure compliant documentation, while presenting findings to regulators and auditors.