Senior Associate Quality Control (Monday - Friday 7:00am - 3:30pm EST)

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.

Senior Associate Quality Control

What you will do

Let’s do this. Let’s change the world.

Under minimal supervision, the Sr. Associate Quality Control staff member will be responsible for the following: Performing testing and data review per various microbiology methods, assisting with sample point and method validation, document writing and review, equipment operation and maintenance, and troubleshooting testing and equipment issues. The QC Sr. Associate is expected to be a strong contributor to the Microbiology testing programs, with the ability to work independently and lead by example while performing in a highly dynamic, team environment.

Perform sample collection, sample handling, and Microbiological testing to support GMP operations across ARI. Perform Microbiological sample and method qualifications including Sterility, Endotoxin, Bioburden, Microbial Identification, qPCR, and other microbiological assays as assigned. Support routine testing for the raw material ARI center of excellence program and for routine in-process DS testing. Support training and qualification for aseptic gowning for manufacturing and QC staff. 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. Write and revise reports, SOPs, and other GMP documents in document management system. Operate and maintain specialized laboratory equipment and instrumentation. Participate in QC laboratory investigations and audits, as necessary. 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 great teammate with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Quality Control work experience OR
• Associate’s + 2 years Quality Control work experience OR
• Bachelor’s + 6 months Quality Control work experience
• Master's

Preferred Qualifications:

• Experience executing microbial test methods, with experience in at least one of the following method families: bioburden, endotoxin, microbial identification, growth promotion, sterility, qPCR, or rapid mycoplasma.
• Experience performing sample point and method validation.
• Technical writing experience in drafting, revising, and reviewing documents in a GMP document management system (CDOCS, EDMQ, etc.)
• Experience in aseptic operations in biological safety cabinet (BSC) or laminar flow hood (LFH) and in aseptic gowning.
• Experience supporting Environmental and Clean Utility Monitoring programs.
• Experience operating and maintaining standard laboratory equipment (pH meter, balance, water bath, biological safety cabinet, and fume hood).
• Ability to lead and conduct investigations through deviations and technical result assessments in DQMS.
• Ability to prioritize multiple workstreams given broad objectives to meet deadlines under minimal supervision.
• Support Operational Excellence initiatives such as Level and Flow, 5S, and Standard Work associated with the testing labs and methods.
• What you can expect from 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.
• 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 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, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team!

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.