Specialist, Quality Control Support - Systems Support

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. Specialist, Quality Control Support What you will do Let’s do this. Let’s change the world. In this vital role you will support deployment, validation, and system administration of Laboratory Systems (LIMS/Reagent Manager/Smart Lab eProcedure). The Specialist, Quality Control System Administrator will report directly to the Manager of Quality Control Support. This role may lead QC Support staff. Leading validation and change management support for ANC Laboratory systems deployment. Ability to implement QC computer system validation and support/administer the system(s) when live in the production environment. Run system administration activities for ANC Laboratory systems deployment. Provide technical guidance on Laboratory IS/IT requirements. Provide incident management support as required. Support application performance monitoring and label printing issues. Identify technical/operational gaps and propose solutions. Lead planning and implementation of QC Laboratory Systems equipment integration for all ANC QC Laboratories along with daily activities. Responsible for training the Amgen NC site as each QC Laboratory system launches in the production environment. Author, revise, and review documents and reports including SOPs, qualification/validation summary reports, technical reports. Support routine activities over the weekends and Amgen holidays as needed. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager of Quality Control Support seeks a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 10 years of Computer System Validation or System Administration experience OR Associate’s degree and 8 years of Computer System Validation or System Administration experience OR Bachelor’s degree and 4 years of Computer System Validation or System Administration experience OR Master’s degree and 2 years of Computer System Validation or System Administration experience OR Doctorate degree Preferred Qualifications: Strong technical Laboratory Systems knowledge required to support deployment and support of Laboratory systems (LIMS/Laboratory Management Electronic Smart Lab). Functional experience and capable of leading Laboratory IS/IT projects. The candidate must have experience with running Laboratory IS/IT change controls within an eQMS. Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Degree in Microbiology, Biology, Biochemistry, or related scientific field. Strong CSV experience with QC Laboratory systems. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. 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! for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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.