QC Sr Associate, Microbiology

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. 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.

QC Senior Associate, Microbiology

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for activities including microbial investigations/assessments, microbiological & analytical testing, sample and data management and equipment, instrumentation operation and maintenance, sample and equipment troubleshooting, assistance with reviewing and authorizing documents and samples, and provide leadership on the QC Microbiology Team while performing in a highly dynamic, team environment.

Responsibilities include:

• Perform microbial assessments and other GMP documentation as required (reports, assessments, sop revisions).

• Support microbial and other QC laboratory investigations.

• Perform Microbiological testing to support GMP operations across ARI.

• Perform Microbiological sample and method qualifications including endotoxin, bioburden, microbial identification, qPCR, and other microbiological assays as assigned.

• Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures.

• Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, and laboratory notebooks.

• Operate and maintain specialized laboratory equipment and instrumentation.

• Lead the team to ensure the daily/weekly Level and Flow for testing is performed.

• Perform general laboratory housekeeping activities and safety inspections.

• 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 a good teammate with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Quality, Microbiology or Operations experience

• Associate’s degree and 2 years of Quality, Microbiology or Operations experience

• Bachelor’s degree and 6 months of Quality, Microbiology or Operations experience

• Master's degree

Preferred Qualifications:

• Professional work experience in a fast-paced, flexible GMP laboratory.

• Leadership ability, to assist with the daily/weekly schedule, routine and non-routine testing and sample collection questions and issues, and equipment troubleshooting.

• Experience executing microbial test methods (i.e. bioburden, endotoxin, microbial identification, growth promotion, qPCR, and mycoplasma).

• Experience supporting Environmental and Clean Utility Monitoring programs.

• Operation, maintenance experience with laboratory equipment.

• Ability to generate and revise methods, reports and SOPs within CDOCs.

• Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, Trackwise, etc.).

• Ability to generate, update, and close deviations and analytical result assessments in Trackwise.

• Demonstrated understanding and use of Maximo and the ability to update and complete work orders.

• Ability to manage and lead Operational Excellence initiatives including Level and Flow, 5S, and Standard Work associated with the testing labs.

• Demonstrated written and oral communication skills, project management and presentation skil