Associate Quality Control

Career Category

Job Description

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.

Associate Quality Control

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The role will be based out of Amgen Rhode Island and will work under the guidance of the hiring manager. It is an administrative shift, Monday through Friday.

The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies from basic wet chemistry identifications and titrations to complex instrumental analysis of a substance’s critical parameters. The team provides these crucial services for the entire Amgen production network, to ensure only the highest quality raw materials are used to create products for our patients.

Responsibilities:

• Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements

• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks

• Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations

• Operate laboratory equipment and instrumentation

• Performs review and approval of assays, documents and records

• Supports Continual Improvement initiatives

• Alerts management of quality, compliance, supply and safety risks

• Participate in laboratory investigations

• Perform general laboratory housekeeping activities

• Completes required assigned training to permit execution of required tasks

• Performs additional duties as specified by management

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 2 years of Quality or Operations experience OR

• Associate’s degree and 6 months of Quality or Operations experience OR

• Bachelor’s degree

Preferred Qualifications:

• Experience performing 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

• Experience leading teams or projects

• 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

• Demonstrated innovative thinking and ability to transform work organizations

• Strong technical writing skills within a highly regulated environment

• Exposure to Operational Excellence initiatives

• Demonstrated ability to navigate through ambiguity and provide a structured problem solving

• Demonstrated ability to deliver on schedule

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.