Specialist Quality Assurance – Drug Substance Deviations Job at Amgen (Juncos)

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. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 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. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility

Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
Provides an additional QA oversight by critically reviewing and challenging deviation designations made at the shop floor to ensure accurate, consistent, and compliant classification
Collaborates with Manufacturing and cross-functional stakeholders to reassess impact, drive alignment, and support sound decision-making
Provides QA oversight by critically reviewing and challenging initial deviation write-ups to ensure accurate reflection of the event
Partners with deviation owners to strengthen event descriptions and ensure a clear, compliant initial resolution
Ensures that required sections, including further processing and continued operations, are completed accurately and within established timelines
Serve as Deviation QA Contact and decision-maker for deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
Ensure that changes 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 are complete, accurate, and compliant with cGMP standards
Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs
Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate
Defend investigation strategies, root cause conclusions, CAPA plans, and product impact assessments 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

Requirements

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

Nice to have

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
Strong independent decision-making skills with the ability to influence others and drive alignment across teams
Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies and contributing to successful inspection outcomes
Proven ability to lead and own complex root cause investigations, including facilitating RCA discussions and driving cross‑functional alignment
Experience supporting drug substance 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
Strong sense of accountability and ownership, with the ability to manage multiple high‑impact deviations simultaneously and deliver timely, compliant outcomes
Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks
Ability to identify systemic quality signals, recurring failure modes, and cross-functional process vulnerabilities through trend analysis and prior occurrence assessment
Experience engaging directly with manufacturing operations, including floor support, process observation, and personnel interviews across multiple shifts
Technically savvy and adaptable, with openness to leveraging 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
Effective English written and verbal communication skills

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions
group medical, dental & vision coverage
life & disability insurance
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

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Specialist Quality Assurance – Drug Substance Deviations

Job Description

Job Responsibility

Requirements

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