Specialist Quality Assurance – Drug Substance Deviations   

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.

Specialist Quality Assurance – Drug Substance Deviations   

What you will do

Let’s do this. Let’s change the world! In this vital role, you will serve as a Quality leader Responsible for ensuring timely and accurate triage of quality events and verification that appropriate resolution has been achieved. Confirms correct deviation classification (e.g., minor vs. major) and ensures all documentation is complete, accurate, and compliant with procedural and regulatory requirements before progressing to the next workflow stage. Serves as a Quality Assurance (QA) point of contact for deviations, providing guidance and support as needed to ensure consistent and compliant deviation management.. 

Specific responsibilities include but are not limited to:

• 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. 
  

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Specialist QA professional we seek is a Quality-driven professional with these qualifications. 

Basic 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  

Preferred Qualifications:

• 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 you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

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Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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. Please contact us to request accommodation.