Quality Control Specialist, Microbiology

Career Category Quality 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-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. Quality Control Specialist, Microbiology What you will do Let’s do this. Let’s change the world. In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment. In this role, you will be responsible for: Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing. Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations. Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk assessments, and product impact assessments. Provide technical expertise for environmental monitoring, bioburden control, microbial identification, contamination control strategies, and laboratory controls. Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events. Coordinate contract laboratory activities, including testing support, data review, investigation collaboration, and approval of associated documentation. Generate and maintain complete, accurate, and inspection-ready documentation using electronic laboratory and quality systems (e.g., LMES, LIMS, CIMS, and Veeva). Partner with Quality, Manufacturing, Engineering, and global microbiology teams to support process improvements, operational excellence initiatives, regulatory inspections, and strategic microbiology projects. 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. Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non-routine microbiological testing. Understanding of manufacturing processes associated with contamination control. Experience supporting regulatory inspections and audit readiness activities. Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready. Professional work experience in a fast-paced, flexible GMP laboratory. Ability to generate, investigate, triage and close deviations and analytical test result assessments in Veeva. Ability to generate and document validation protocols and reports. 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 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 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 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. 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. 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. . Salary Range 100,450.45USD -135,903.55 USD