Compliance System Owner - Remote

Overview

As a Compliance System Owner at Amgen, you will oversee all compliance aspects at the Inspection lines, ensuring quality and compliance through various engineering and documentation processes.

In Short

• Oversee compliance aspects at Inspection lines.
• Support or lead on deviations, CAPAs, and audits.
• Conduct root cause analysis and document findings.
• Develop and execute equipment testing protocols.
• Review and update validation protocols and SOPs.
• Collaborate with peers to ensure document quality.
• Create and refine engineering policies and procedures.
• Manage equipment lifecycle using Maximo.
• Work with cross-functional teams on system modifications.
• Engage with vendors to troubleshoot equipment issues.

Requirements

• Master’s degree in Engineering or Bachelor’s with 2 years of experience.
• Experience in a GMP-regulated environment.
• Strong problem-solving skills and root cause investigation experience.
• Knowledge of inspection processes and CAPAs.
• Proficiency in statistical analysis and DOE methodologies.
• Effective communication skills in Spanish and English.
• Availability for non-standard shifts.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plan with company contributions.
• Group medical, dental, and vision coverage.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.