Specialist Manufacturing

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Specialist Manufacturing What you will do Let’s do this. Let’s change the world. The External Supply (ES) Raw Material and Devices Quality Records (RMD QRO) global team plays a vital role in supporting the Amgen manufacturing network. Our work includes managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, sites, and managing life-cycle changes to existing materials or suppliers. The External Supply Specialist Manufacturing is expected to own and execute independently all the processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications. This Specialist Manufacturing will act as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the global Amgen network. Responsibilities: Responsibilities include, but are not limited to the following: Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements. Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes. Partner cross-functionally across the network to ensure maturity and execution of robust quality record process. Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.) Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV). Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics. Build and present quality record summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management in multiple forums and keeping tracking tools updated. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR Bachelor’s degree and 4 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR Associate’s degree and 8 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR High school diploma / GED and 10 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries Preferred Qualifications: 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems. Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System Project Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule. Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction. Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff. Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively. Experience presenting to and interacting with representatives of regulatory agencies. Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach. Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites. Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook) Experience navigating and executing transactions in SAP (ERP) or S4HANA system. Experience applying AI-enabled tools in a regulated environment. Experience contributing to the design, development, or implementation of AI-enabled tools as part of process improvement initiatives or projects. Ability to translate business or quality process needs into practical solutions and evaluate outputs for accuracy, data integrity, and compliance with applicable requirements Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met. Ability to tactfully negotiate and positively influence peers and executive leadership. Demonstrated ability to deliver results through living the Amgen values. Strong negotiation skills when working with external suppliers and internal team members. Ability to maintain remote working relationships with colleagues at other Amgen sites. 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. 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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. #J-18808-Ljbffr Amgen Inc.