Associate Quality Control

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.

Associate Quality Control - Days

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform routine procedures and testing in support of the Microbiology, Endotoxin Testing, PCR, TOC, Conductivity Testing group. This position will be responsible for one or more of the following activities:

- Performing routine laboratory procedures
- Routine analytical testing
- Documenting, computing, compiling, interpreting and entering data
- Maintaining and operating specialized equipment
- Initiating and / or implementing changes in controlled documents. Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks.
Shift
:
Monday
- Friday 7am - 3:30pm

• Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures. This includes bioburden, endotoxin, sterility, growth promotion, and microbial  along with additional microbiological testing.
• Perform bioburden, endotoxin, and sterility validation testing for product, raw materials, and component sample types.
• Initiate deviations and TRAs for quality events in DQMS
• Draft and review documents in CDOCS, as needed.
• Perform gowning monitoring certification sampling in the manufacturing grade 5 environment
• 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.

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 detail oriented with these qualifications.

Basic Qualifications:

• High school diploma / GED and 2 years of Quality experience OR
• Associate’s degree and 6 months of Quality experience OR
• Bachelor’s degree

Preferred Qualifications:

• Professional work experience in a fast-paced, flexible GxP laboratory
• Experience executing microbial test methods (i.e. bioburden, endotoxin, microbial identification, growth promotion, qPCR, and mycoplasma)
• Experience drafting/revising and managing document workflows in CDOCS
• Experience initiating deviations and TRAs in DQMS
• Expe…