Amgen Inc
Specialist Quality Assurance - Major Deviations
US - Puerto Rico - Juncos
Sponsorship not specifiedDetected 1 day ago
GMPResearchLeadershipCollaborationCritical ThinkingWritingAdaptabilityGxP
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odds of building a lasting career here
42Risky
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 92%
Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Join Amgen's Mission of Serving Patients
- At Amgen, if you feel like you're part of something bigger, it's because you are.
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
Responsibilities
- Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure.
- 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.
- 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.
Requirements
- 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
- Collaborate cross functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required is complete and accurate.
- Complete required training and perform additional duties as assigned by management.
Nice to have
- 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.
- 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.
- 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.
Compensation
- As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfa
Company info
- Career Category Quality Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What we expect of you We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- Equal Opportunity employer.
- Please contact us to request accommodation
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
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This listing is sourced directly from Amgen Inc's careers page and normalized into a canonical job model.