Quality Assurance Lead - Major Deviations Investigator

Amgen; Puerto Rico; On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen seeks a Specialist Quality Assurance to lead major deviation investigations, ensuring product quality and patient safety in a GMP environment. You'll drive cross-functional collaboration with Manufacturing, Engineering, Validation, and Quality to resolve deviations and prevent recurrence.

Responsibilities include leading investigations, documenting outcomes, and escalating risks as needed. Strong root-cause and CAPA experience are essential, with a focus on data-driven decisions.

Qualifications

• We are seeking a quality-driven professional with ownership and accountability.
• Experience documenting Deviations, CAPA, and CAPA Effectiveness Verification in GxP.
• Ability to lead root cause investigations and RCA discussions.
• Ability to engage manufacturing, engineering and quality teams cross-functionally.

Responsibilities

• Lead quality investigations for major deviations and ensure timely closure.
• Actively participate in deviation meetings and manage multiple deviations.
• Provide quality oversight for deviation documentation across shifts.
• Escalate quality, compliance, and patient-safety risks to senior management.
• Support continuous improvement and leverage learnings from deviations.

Skills

Quality-driven

Cross-functional collaboration

Root cause analysis

Investigations leadership

Documentation

Education

Doctorate degree

Master's degree + 2 years QA experience

Bachelor's degree + 4 years QA experience

Associate's degree + 8 years QA experience

High school diploma / GED + 10 years QA experience

Job description

Amgen seeks a Specialist Quality Assurance to lead major deviation investigations, ensuring product quality and patient safety in a GMP environment. You'll drive cross-functional collaboration with Manufacturing, Engineering, Validation, and Quality to resolve deviations and prevent recurrence.

Responsibilities include leading investigations, documenting outcomes, and escalating risks as needed. Strong root-cause and CAPA experience are essential, with a focus on data-driven decisions.