AddressHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Specialist, Quality
Live
What you will do
Let’s do this! Let’s change the world!
We at Amgen care deeply about our mission to serve patients and our core values, which include “Ensure Quality.” In this role, candidate will join the Global Quality Control network and have a key role in E2E Quality Transformation and the QC Optimization Initiative. Seeking an Operational Excellence Professional with a deep understanding of the Quality Control lab. In addition, must have comprehensive project management skills. Because we believe standard work is a cornerstone of any lean operation this role demands an expert in operational excellence principles, initially in standard work (SW) practices across various testing platforms in a biotech environment. Initially the candidate will be responsible for driving the QC network standard work program. This includes maintaining, improving, and developing SW for all phases of QC. Tracking network performance, training staff, and providing technical support are important aspects of this position. A highly desirable candidate will have a passion for continuous improvement in the quality control environment and will creatively find ways to sustainably implement SW into the DNA of the QC network. This position will also explore and support other operational excellence opportunities that will differentiate the QC network as a competitive advantage for Amgen.
Key Responsibilities:
Standard Work Oversight:
Own and ensure the effective implementation of standard work across all testing platforms.
Develop, maintain, and update the site tracking tool to trend site results, ensuring high levels of accuracy and reliability.
Proactively identify issues with existing standard work requiring resolution or improvement.
Standard Work Development and Improvement:
Lead the development of new standard work processes, ensuring they meet industry best practices and regulatory standards.
Develop and execute a plan to build standard work for non-testing tasks.
Drive year-over-year productivity improvements through efficient and innovative standard work strategies.
Provide technical support and training during the design, generation, implementation, and/or improvement of standard work processes.
Training and Support:
Assist in training new staff on standard work procedures, ensuring a high level of competency and adherence.
Serve as a key resource for technical support related to standard work, helping teams navigate complex processes and changes.
Performance Tracking and Contribution:
Contribute to tracking and analyzing network performance, identifying trends, and suggesting actionable improvements.
Utilize data analytics and quality control insights to enhance operational efficiency and effectiveness.
Conduct detailed budget analysis to identify spending trends, evaluate budget proposals, and ensure alignment with the organization’s financial goals.
Implement productivity models to optimize operational efficiency and support cost-reduction initiatives.
Analyze financial data to identify opportunities for process improvements and recommend strategies to enhance financial performance.
Collaboration and Leadership:
Collaborate with various teams to ensure standard work processes are integrated and aligned with overall operational goals.
Lead cross-functional teams in the implementation of operational excellence initiatives, fostering a culture of continuous improvement.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Project Management, Quality and/or Operations experience OR
Master’s degree and 6 years of Project Management, Quality and/or Operations experience OR
Bachelor’s degree and 8 years of Project Management, Quality and/or Operations experience OR
Associate’s degree and 10 years of Project Management, Quality and/or Operations experience OR
High school diploma / GED and 12 years of Project Management, Quality and/or Operations experience
Preferred Qualifications:
Bachelor or Master degree in Biotechnology, Engineering, or a related field.
Experience in project management, operational experience, and financial analysis within a biotech or laboratory setting.
Expertise in operational excellence with a focus on standard work in lab operations and quality control.
Certifications in Operational Excellence and Six Sigma (Green Belt, Black Belt, or similar) preferred.
Strong experience in the biotech industry, particularly in quality control and laboratory operations.
Effective communication skills, both written and verbal, with the ability to present complex data in an understandable manner.
Excellent analytical, problem-solving, and decision-making skills, with a high level of accuracy in calculations and forecasting.
Ability to translate complex financial data into clear, actionable insights for non-financial team members.
Strong organizational skills, with the ability to manage multiple projects simultaneously and meet tight deadlines.
Thrive
What you can expect of us
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.
Amgen offers a Total Rewards Plan comprising 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 including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.
