Amgen Inc

Specialist Quality Assurance (Second Shift)

US - Puerto Rico - Juncos

Sponsorship not specifiedDetected 10 hours ago

GMPResearchLeadershipCollaborationCritical ThinkingWritingAdaptabilityGxP

About the role

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

Serve as Quality investigation lead and decision-maker for complex deviations, maintaining accountability for designation, documentation quality, timeliness and closure.
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.

Doctorate degree
Master's degree and 2 years of Quality Assurance experience
Bachelor's degree and 4 years of Quality Assurance experience
Associate's degree and 8 years of Quality Assurance experience
High school diploma / GED and 10 years of Quality Assurance experience
Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts, including nights when required.
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required for designation and/or closure of deviations is complete and accurate.
Complete required training and perform additional duties as assigned by management.

Life Science and/or Engineering academic degree.
Advanced experience in Quality Systems, with demonstrated expertise documenting Deviations, CAPA, and CAPA Effectiveness Verification (EV) within a regulated GxP environment.
Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contributing to successful inspection outcomes.
Experience supporting drug product operations in a GMP-regulated environment.
Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices.
Ability to identify systemic quality signals, recurring failure modes, and cross-functional process vulnerabilities through trend analysis and prior occurrence assessment.
Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI‑enabled tools) to improve investigation effectiveness.
What you can expect of us

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals,

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
Please contact us to request accommodation.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.