Senior Associate Quality Control, Environmental and Utilities Monitoring

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control, Environmental and Utilities Monitoring

What you will do

Let’s do this. Let’s change the world. In this vital role you will be performing testing within the Quality Control Microbiology laboratory. Responsibilities will include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program to deliver site start up and then transition to testing in support of Amgen North Carolina commercial product release. Scope includes in-process, release, stability and routine monitoring testing. The Senior Associate Quality Control Microbiology will report directly to the Quality Control Specialist of Microbiology

• Assist with planning and execution of EMPQ activities to support establishment of environmental monitoring program.
• Support routine environmental monitoring and utilities sampling and testing.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Collecting and preparing samples for analysis, ensuring proper labeling and documentation.
• Plan and execute routine sample collection for environmental monitoring in classified areas.
• Assist with planning and execution of clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems.
• Execute sample collection for routine utilities' monitoring.
• Assist with general lab maintenance activities and 5S.
• Perform routine tasks such as cleaning and inventory management.
• Support routine activities over the weekends and public holidays as required.
• Acting as a source of knowledge for all environmental monitoring & utilities monitoring areas
• Author, revise, and review documents and reports including but not limited to: SOPs, protocols, safety assessments, methods, trend reports, qualification/validation summary reports, microorganism assessments, technical reports, and method assessments.
• Oversight and Training of junior staff, including but not limited to creating and maintaining schedule for environmental and utilities monitoring.
• Own, manage, and participate in deviations, CAPAs, and cross functional investigations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is an experienced quality control analyst with these qualifications.

Basic Qualifications:

• High School diploma/GED and 4 years of related GxP laboratory experience OR
• Associate’s degree and 2 years of related GxP laboratory experience OR
• Bachelor’s degree and 6 months of related GxP laboratory experience OR
• Master’s degree

Preferred Qualifications:

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in Microbiology, Biology, Biochemistry, or related scientific field.
• Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC.
• Strong knowledge of aseptic technique.
• Experience with environmental monitoring and clean utilities' monitoring, and trending of EM/utilities data.
• Proficient in Good Documentation Practices.
• Ensure precision in sample collection, data recording, and equipment handling.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Experience with equipment validation.
• Experience with method transfer, verification, and validation.
• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.
• Experience owning, managing, and participating in deviations, CAPAs, and cross functional investigations.

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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

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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.