QC Specialist, Microbiology

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. QC Specialist, Microbiology What You Will Do Let’s do this. Let’s change the world. In this vital role you will be responsible for the following activities including: Lead QC Laboratory investigations in the areas of microbiology and environmental monitoring Support Manufacturing deviation investigations from microbiology perspective Document microbial assessment reports Revise GMP documents associated with microbiology investigations and other activities to support CAPA and Change Controls Support process improvements and other microbiology projects In addition to the tasks above, QC Specialist will perform the following: Support the global network for initiatives and projects that impact microbiology groups Support and document trending analysis, validation protocols/reports, and change controls Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, CIMS and laboratory notebooks Train on assays that support microbial identification activities Operate and maintain specialized laboratory equipment and instrumentation Lead the team to ensure the daily/weekly tasks are 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 self‑starter with these qualifications. Basic Qualifications High school diploma / GED and 10 years of Quality, Microbiology or Operations experience OR Associate’s degree and 8 years of Quality, Microbiology or Operations experience OR Bachelor’s degree and 4 years of Quality, Microbiology or Operations experience OR Master’s degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree Preferred Qualifications Microbiology degree and/or microbiology laboratory experience associated with microbial identification. Understanding of manufacturing processes associated with contamination control Professional work experience in a fast‑paced, flexible GMP laboratory. Leadership ability, support routine and non‑routine testing, method and equipment troubleshooting. Ability to generate, investigate, and close deviations and analytical result assessments in Veeva. Ability to generate and document validation protocols and reports. Ability to evaluate data for trends and document corrective actions. Experience performing aliquoting of samples aseptically. Operation, maintenance experience with laboratory equipment. Ability to generate and revise methods and SOPs within CDOCs. Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.). Demonstrated understanding and use of Maximo (Work order System) 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 skills, and proven ability to manage priorities effectively. Demonstrated ability to be flexible and adaptable to support business needs. 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. 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. 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 where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. 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. Sponsorship: Sponsorship for this role is not guaranteed. 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. #J-18808-Ljbffr Amgen