Sr Specialist Quality

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Specialist Quality

What you will do

Lets do this! Lets change the world!

At Amgen we are deeply committed to our mission to serve patientsand our core values including Ensure Quality are at the heart of everything we do. As part of our continued focus on innovation and excellence we are advancing our QC Digital Optimization Initiative as part of the broader EndtoEnd Quality Transformation.

We are looking for a highly skilled Sr. Specialist in Quality Control (QC) with strong data analytics expertise to join our Global QC Network Team. This role offers an exciting opportunity to be a key contributor to the QC Digital Optimization Product Team where youll transform how QC laboratories operate by using data to enhance quality efficiency and compliance.

In addition to technical responsibilities this role will serve as a Business Process Owner (BPO) for QC standardization efforts. You will drive global alignment and standardization of analytical platforms and laboratory equipment working crossfunctionally with Analytical Sciences Digital Technology & Innovation (DTI) and other partners to influence both current operations and upstream strategies for new product introductions (NPIs).

Key Responsibilities

• Analyze and interpret complex QC data from lab instruments manufacturing systems and digital platforms to improve process efficiency and datadriven decisionmaking.

• Collaborate with QC analysts and global partners to develop datadriven strategies for quality improvement and regulatory compliance.

• Contribute to innovation in digital QC strategies including predictive analytics process monitoring and big data analysis.

• Serve as Business Process Owner for global QC standardization leading initiatives to align equipment data systems and methods across sites.

• Collaborate with Analytical Sciences and DTI to lead upstream efforts for analytical platform standardization particularly in support of new product introductions (NPIs).

• Lead crossfunctional alignment on equipment lifecycle and platform strategies through the Global Laboratory Asset Management (GLAM) program.

• Leverage structured and unstructured datasets from systems such as LIMS MES and realtime monitoring tools ensuring data integrity and traceability.

• Design and automate QC reporting and dashboards using Power BI Tableau Python or other tools for realtime visualization and insights.

• Integrate digital tools AI and automation to streamline QC workflows and improve laboratory performance.

• Partner with IT data engineering and digital transformation teams to enhance QC data infrastructure accessibility and analytics capability.

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

• Masters degree and 4 years of Project Management Quality and/or Operations experience OR

• Bachelors degree and 6 years of Project Management Quality and/or Operations experience OR

• Associates 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:

• Bachelors or Masters degree in a relevant field such as Data Science Chemistry Biochemistry Pharmaceutical Sciences Engineering or a related field.

• 5 years of experience in Quality Control (QC) or Manufacturing setting with a strong focus on QC data analysis and digital optimization.

• Demonstrated leadership in digital transformation and standardization across QC systems and equipment.

• Experience leading crossfunctional initiatives with Analytical Sciences and IT functions to support upstream standardization.

• Knowledge of new product introduction (NPI) processes and how they relate to laboratory readiness and platform selection.

• Deep knowledge of laboratory operations analytical testing quality control workflows and regulatory requirements (e.g. GMP GLP FDA ISO standards).

• Proficiency in data science and analytics tools such as Python R SQL or MATLAB.

• Experience with LIMS MES ELN and other digital QC systems to extract analyze and interpret complex datasets.

• Strong background in statistical data analysis process monitoring and root cause investigations in QC environments.

• Experience working with big data platforms cloudbased analytics (AWS Azure GCP) and automation tools for QC data integration.

• Ability to translate complex QC datasets into actionable insights to enhance laboratory efficiency compliance and decisionmaking.

• Experience in the biotech pharmaceutical or medical device industries with a strong emphasis on regulated QC environments.

• Understanding of data governance audit trail requirements and data security in a lab setting.

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 wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

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 and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

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

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

Salary Range