Micro/EM Associate QC I

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‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients by researching, manufacturing, and delivering innovative medicines that help people live longer, fuller, happier lives. Micro/EM Associate QC I What you will do In this vital role you will be performing testing within the Quality Control Microbiology laboratory. Responsibilities include sampling and testing to support clean utilities qualification and establishment of the environmental monitoring program, delivering site start‑up, and then transitioning to testing in support of Amgen North Carolina commercial product release. Scope includes in‑process, release, stability, and routine monitoring testing. The Associate Quality Control, Environmental and Utilities Monitoring will report directly to the Manager of Microbiology. Support document review and authoring, including SOPs, safety assessments, methods, trend reports, microorganism assessments, and technical reports. Assist with execution of EMPQ activities to support establishment of environmental monitoring program. Perform routine environmental monitoring and utilities sampling. Perform routine quality control testing, including bioburden, endotoxin, conductivity, and TOC. Participate in audits, initiatives, and projects that may be interdepartmental or global in scope. Participate in deviations, CAPAs, and cross‑functional investigations. Assist with general lab setup and 5S. Support routine activities over weekends and public holidays as required. Assist with clean utilities performance qualifications, including water for injection, clean steam, clean compressed air, oxygen, and carbon dioxide distribution systems. Perform routine tasks such as cleaning and inventory management. What we expect of you We are all different, and we value the unique contributions of each team member. The motivated professional we seek is a quality control professional with the following qualifications. Basic Qualifications High school/GED + 2 years of related GxP laboratory work experience OR Associate’s + 6 months of related GxP laboratory work experience OR Bachelor’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 a related scientific field. Experience with microbiological quality control testing, including endotoxin, bioburden, microbial identification, TOC, and PCR. Strong knowledge of aseptic technique. Experience with environmental monitoring and clean utilities monitoring. Proficiency in Good Documentation Practices. Strong written and verbal communication skills, including technical writing and presentations. Ability to work independently with minimal supervision and collaboratively on group tasks. What you can expect of us We work to develop treatments that care for others and we care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we support your journey every step of the way. 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. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.