Senior Specialist Quality Control – Technical Resources

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. 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.

Senior Specialist Quality Control – Technical Resources

What you will do

Let’s do this. Let’s change the world! In this vital role you will be the technical specialist for Amgen Manufacturing Limited, QC Operations. You will serve as a key technical leader supporting the Quality Control (QC) laboratories. You will be responsible for addressing complex technical challenges with cross-functional, multi-site, and external impact. Collaborating across Quality Control, Quality Assurance, Manufacturing, Engineering, and Process Development, your work will be critical in ensuring the robustness and reliability of lab operations.

Specific responsibilities include but are not limited to:

• Technical Expertise & Troubleshooting - Provide hands-on technical guidance and expert-level troubleshooting for analytical assays and laboratory equipment, ensuring high-quality and timely support across QC operations.
• Data & Reporting - Conduct data analysis, generate technical reports, and maintain effective communication with cross-functional technical teams. Follow up on open items and drive issues to resolution.
• Compliance & Safety Leadership - Ensure strict adherence to cGMP, GLP, and safety standards. Drive compliance through the development and implementation of procedures that enhance quality and safety across lab operations.
• Laboratory Optimization - Lead initiatives to improve equipment reliability and maintenance using optimization techniques. Champion programs that elevate laboratory performance and minimize downtime.
• Controlled Documentation - Create, revise, and audit complex controlled documents with potential multi-site impact. Ensure documentation aligns with regulatory and corporate requirements.
• Audit & Inspection Readiness - Lead QC efforts during internal and external inspections. Serve as a key representative and subject matter expert (SME) for laboratory equipment and operations.
• Training & Capability Building - Develop and deliver technical training programs for laboratory staff. Promote knowledge transfer and continuous improvement initiatives.
• Quality Systems Oversight - Manage quality system records, lead laboratory investigations, and support continuous improvement of quality processes.
• Cross-functional Collaboration - Represent QC Operations on cross-functional teams and global initiatives. Independently manage and drive multi-site action items to closure.
• Regulatory Engagement - Support regulatory inspections and responses as an SME within area(s) of responsibility.
• Financial & Vendor Management - Oversee operational financials, including procurement activities, contract execution, and purchase order management for laboratory services and equipment.
• Special Projects - Lead or support strategic projects assigned by management to drive innovation and efficiency.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Sr Specialist QC professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of quality control and/or laboratory experience

OR

Master’s degree and 4 years of quality control and/or laboratory experience

OR

Bachelor’s degree and 6 years of quality control and/or laboratory experience

Or

Associate’s degree and 10 years of quality control and/or laboratory experience

Or

High School diploma / GED and 12 years of quality control and/or laboratory experience

Beyond that, additional preferred qualifications are:

• Academic background in Life Sciences.
• 10+ years of professional experience, including at least 4 years in cGMP-regulated environments within Quality Control, Laboratory Operations, Validation, or Quality Assurance.
• Exceptional proficiency in analytical method qualification, validation, and transfer processes as well as their associated international guidance and regulatory requirements.
• Strong technical background with laboratory equipment operation, troubleshooting, maintenance, and optimization in multiple analytical platforms (molecular biology, chemistry and/or microbiology).
• Demonstrated experience managing quality systems, including Change Controls, CAPA, deviations, and investigations.
• Proficient in cGMPs/GLPs, domestic and international regulatory standards, and experienced in regulatory inspection readiness and response.
• Excellent technical writing, facilitation, and verbal communication skills in English; capable of authoring SOPs, protocols, and regulatory documentation clearly and effectively.
• Skilled in data analysis, digital systems (LIMS, Empower), and Microsoft Office applications (Excel, Word, PowerPoint).
• Proven ability to lead cross-functional teams and projects, with strong influencing, organizational, and project management capabilities, including budget oversight and capital project execution.
• Strong commitment to EHS practices and promoting a culture of laboratory safety and compliance.

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, life and 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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.