QC Manufacturing - Team B Associate Quality Control

Career Category Operations 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. 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 be responsible for activities including microbiology & analytical testing, sample and data management, as well as equipment and instrumentation operation and maintenance in a highly dynamic, team environment. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring within Manufacturing and Utility areas. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures.

This includes bioburden, endotoxin, TOC, conductivity, and MMV testing along with additional daily microbiological testing. Use of testing and data review within automated sampling systems, such as LIMS, LMES, and CIMS. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. Operate and maintain specialized laboratory equipment and instrumentation. Participate in laboratory investigations and audits as necessary.

Perform general laboratory housekeeping activities. Maintain training compliance and proficiency. At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

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

Basic Qualifications:

Bachelor’s OR Associate’s + 6 months quality experience OR High school/GED + 2 years quality experience

Preferred Qualifications:

Professional work experience in a fast‑paced, flexible GxP laboratory Experience executing test methods for microbiology, i.e. bioburden and endotoxin testing. Experience with gowning and sampling within clean room areas. Operation, maintenance experience with laboratory equipment. Demonstrated proficiency with electronic systems (LIMS, LMES, Trackwise, etc.). Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S. Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.

Demonstrated ability to be flexible and adaptable to support business needs.

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,…