QA Specialist

Career CategoryOperationsJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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.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 Assurance Specialist Let’s do this.  Let’s change the world.  The Quality Assurance (QA) Technical Services Specialist is a critical role for the ARI site.  The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC).  Because the function is engaged with complex investigations and delivery of site strategic priorities, the role offers the opportunity to engage broadly across the ARI site and within the network.  QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines.  This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system.Key Responsibilities include:Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.Develop and maintain a working understanding of applicable requirements and best practices.Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change controlManage the change control process, ensuring changes and implementation strategies are thoroughly evaluated for impact to quality.Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk ManagementCollaborate with project teams to integrate quality considerations and controls into project planning and execution.Independently assess and prioritize quality risks across various functions and processes.Implement proactive measures to prevent potential issues and ensure a state of inspection readinessMaintain relationships within the Amgen network to help benchmark and share best practices.Drive continuous improvement initiatives at the site and network level to create value for the business.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great teammate with these qualifications.Basic Qualifications:High school diploma / GED & 10 years of Quality and/or Manufacturing experience ORAssociate’s degree & 8 years of Quality and/or Manufacturing experience ORBachelor’s degree & 4 years of Quality and/or Manufacturing experience ORMaster’s degree & 2 years of Quality and/or Manufacturing experience ORDoctorate degreePreferred Qualifications:Demonstrated experience leading enterprise risk management within GxP environments, including development of risk frameworks, predictive KPIs, escalation governance models, and cross-functional mitigation strategies to proactively identify and reduce quality and supplier-related risks.Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs), ensuring robust quality system integration, supplier readiness, risk assessments, change control oversight, and seamless alignment with regulatory and inspection readiness expectations across global networks.Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPAExcellent written and verbal communication skills with cross functional teams, network, and management.Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.Experience with Regulatory inspections.What you can expect from usAs 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 Re