Quality Assurance Specialist - Major Deviations Investigator

Amgen SA; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen seeks a Specialist Quality Assurance professional for major deviations, focused on leading investigations and ensuring product quality and patient safety in a dynamic drug product environment.

The role requires strong assessment of deviations, rigorous documentation, and collaboration across Manufacturing, Engineering, Validation, and Quality to reach timely, compliant outcomes.

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate or High school + experience in QA
• Experience documenting Deviations, CAPA, and CAPA Effectiveness Verification in GxP
• Proven ability to lead root cause investigations and drive cross-functional alignment
• Experience supporting regulatory inspections and audits
• Proficient technical writing and ALCOA+ practices

Responsibilities

• Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure
• Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution
• Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts
• Ensure deviations with potential impact to product quality are properly assessed and documented per procedures
• Verify that deviations are investigated, documented, and resolved per Quality System requirements
• Ensure production records, laboratory results, and investigation documentation used as evidence are complete and compliant with cGMP
• Review, approve, and track cGMP documentation including Deviations and procedure updates
• Demonstrate strong critical thinking using evidence-based decision making
• Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Quality to ensure information is complete and accurate

Skills

Quality Assurance

Investigations

Risk management

Cross-functional collaboration

Education

Doctorate degree

Master’s degree and 2 years QA experience

Bachelor’s degree and 4 years QA experience

Associate’s degree and 8 years QA experience

High school diploma / GED and 10 years QA experience

Tools

Quality Systems

cGMP standards

AI tools (benign use)

Job description

Amgen seeks a Specialist Quality Assurance professional for major deviations, focused on leading investigations and ensuring product quality and patient safety in a dynamic drug product environment.

The role requires strong assessment of deviations, rigorous documentation, and collaboration across Manufacturing, Engineering, Validation, and Quality to reach timely, compliant outcomes.