Lead Quality Assurance Investigator – Major Deviations & AI

Amgen; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Stock‑based long‑term incentives

Discretionary annual bonus

Flexible work models where possible

Job summary

Amgen is seeking a Specialist Quality Assurance – Major Deviations to lead investigations of critical deviations, safeguard product quality and patient safety, and collaborate across Manufacturing, Engineering, Validation, and Quality teams in a dynamic drug product environment. You will oversee deviation documentation, CAPA, and regulatory readiness, using AI tools where appropriate.

The role requires advanced QA experience, strong writing skills, and a proven ability to drive timely, compliant

Qualifications

• Doctorate degree OR Master’s degree and 2 years of Quality Assurance experience OR Bachelor’s degree and 4 years of Quality Assurance experience OR Associate’s degree and 8 years of Quality Assurance experience OR High school diploma / GED and 10 years of Quality Assurance experience
• Academic degree in Microbiology, Engineering, Chemistry, or a related scientific field.
• Experience supporting drug product operations in a GMP‑regulated environment.
• Advanced experience in Quality Systems, with demonstrated expertise documenting Deviations, CAPA, and CAPA Effectiveness Verification (EV) within a regulated GxP environment.
• Proven ability to lead root cause investigations, facilitate RCA discussions, influence others, and drive cross‑functional alignment.
• Demonstrated accountability and ownership in managing multiple high‑impact deviations and delivering timely, compliant outcomes.
• Demonstrated ability to evaluate compliance issues and use trend analysis and prior occurrence assessments to identify systemic quality signals, recurring failure modes, process vulnerabilities, and quality risks.
• Experience engaging directly with manufacturing operations, including floor support, process observation, and personnel interviews across multiple shifts.
• Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contributing to successful inspection outcomes.
• Proficient technical writing skills with the ability to produce concise, objective, evidence‑based, inspection‑ready documentation in compliance with ALCOA+ and Good Documentation Practices.
• Technically savvy and adaptable, with openness to using digital tools, automation, and emerging technologies (including AI‑enabled tools) to improve investigation effectiveness.
• Flexibility to support variable schedules and cross‑time‑zone interactions, while consistently demonstrating Amgen Values and Leadership 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 that deviations with potential impact to product quality are properly assessed and documented per established procedures.
• Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements.
• Ensure production records, laboratory results, and investigation documentation to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards.
• Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records.
• Demonstrate strong critical thinking skills using evidence‑based decision making.
• Use approved AI tools, as applicable, to support major deviation activities, such as reviewing records, organizing evidence, identifying trends, and drafting investigation content.
• Verify AI‑generated outputs for accuracy and maintain accountability for decisions and final documentation.
• Collaborate cross functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required is complete and accurate.
• Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate.
• Defend deviations during internal audits, regulatory inspections, and leadership review forums.
• Maintain flexibility to support network interactions across time zones and operational needs requiring schedule adaptability.
• Support Continuous Improvement initiatives, leveraging deviation learnings to strengthen systems and prevent recurrence.
• Complete required training and perform additional duties as assigned by management.

Skills

Quality leadership

Root cause investigations

Cross-functional collaboration

Regulatory inspections experience

Technical writing

Digital tools / AI-enabled tools

GxP / cGMP knowledge

Education

Doctorate or Master’s + QA experience

Bachelor’s + QA experience

Associate + QA experience

High school diploma + 10 years QA

Job description

Amgen is seeking a Specialist Quality Assurance – Major Deviations to lead investigations of critical deviations, safeguard product quality and patient safety, and collaborate across Manufacturing, Engineering, Validation, and Quality teams in a dynamic drug product environment. You will oversee deviation documentation, CAPA, and regulatory readiness, using AI tools where appropriate.

The role requires advanced QA experience, strong writing skills, and a proven ability to drive timely, compliant