Sr. Specialist Quality Assurance (QA)

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.

Sr. Specialist Quality Assurance (QA)

Let’s do this. Let’s change the world. In this vital role you will

Serve as Subject Matter Expert for disposition QA roles, disposition transactions, and Quality Master Data in SAP. Provide assessment, guidance, review, and approval for disposition processes and Quality Master Data in SAP to ensure completeness and accuracy, sound rationale, and alignment to regulatory expectations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and implement necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of deviation requests related to SAP. Participate in and support regulatory inspections.

• Provide business assessment on impact from SAP system changes related to disposition and Quality Master Data
• Provide guidance on setup of Quality Master Data in SAP
• Own relevant controlled documents including SOPs, forms, guidelines, and specifications related to SAP functionality, transactions, reports, functionality, and roles
• Review operational SOP’s and Work Instructions related to SAP
• Approve access for SAP QA Roles from sites and review user access roles to ensure segregation of duties and no excess access
• Own SAP QA training material
• Initiate, own, or support as QA approver QA Deviations (Major, Minor) and CAPAs as needed
• Review and approve Data Integrity Assessments
• Support the Global Network for Disposition Process and Global Raw Material Sampling and Inspection
• Help to solve production issues related to Quality Master Data, disposition processes, Quality SAP reports, reclassification, sampling, posting of stock, shipments and movement of materials to various stock statuses
• Support inspections/audits related to Quality Module and batch numbering scheme in SAP
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Trend data
• Anticipate and prevent potential problems
• May be responsible for specific programs and/or projects
• Independently develop solutions that are thorough, practical and consistent with functional objectives

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Bachelor’s degree in computer science or related field and 5+ years of Software and Systems Quality assurance experience
• 10 years of demonstrated ability working directly with SAP and performing business assessments related to system changes
• Deep Technical knowledge of SAP, SAP disposition functions, and Quality Master Data in SAP
• Experience owning and serving as QA Contact for Major and Minor Deviations
• Ability to interpret and apply GLPs, GCP’s and GMPs
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
• Provides training and guidance to others
• Extends capabilities by working closely with senior staff/ experts within and outside the internal organization

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 competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

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

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.