Specialist QC

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.

Let’s do this. Let’s change the world. In this vital role you will provide leadership and support for QC Centralized Raw Material Testing in the Instrumentation Laboratory at Amgen Rhode Island.

The Specialist QC will contribute directly and provide support to core laboratory operations, including:

• Routine Raw Material Testing
• Review/Approval of results in LIMS
• Interfacing with CTLs and entering results in LIMS
• Support for troubleshooting and problem solving
• Support for method validations
• Oversight of material onboarding
• Lab Point of Contact for Compendial Compliance
• Site SME for instrumentation methods, procedures, equipment, etc.
• Support with quality records (e.g. TRA ownership, Minor deviation initiation, and SME for Major deviations)
• Document ownership for Raw Material testing procedures
• Provide leadership by mentoring and coaching team
• Instructor for multiple methods/equipment
• Presents during audits and inspections

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self‑starter with these qualifications.

• High school diploma / GED and 10 years of Quality or Operations experience OR
• Associates degree and 8 years of Quality or Operations experience OR
• Bachelors degree and 4 years of Quality or Operations experience OR
• Masters degree and 2 years of Quality or Operations experience OR
• Doctorate degree

• Experience leading teams, projects, programs or directing the allocation of resources
• Experience executing analytical testing per Methods and/or Compendia
• Experience with QC analytical systems and/or Quality systems
• Excellent interpersonal, written and verbal communication skills with all levels within the organization
• Ability to work in a team matrix environment and build relationships with partners
• Identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across different functions
• Experience in auditing and defending processes, procedures and decisions during regulatory inspections
• Strong leadership and negotiation skills with a demonstrated ability to influence different styles
• Strong quality mindset
• Demonstrated innovative thinking and ability to transform work organizations
• Strong technical writing skills within a highly regulated environment
• Demonstrated ability to navigate through ambiguity and provide a structured problem solving
• Demonstrated ability to coordinate multi‑functional project teams and deliver on schedule

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 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…