Senior Associate QA, International Distribution Quality

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. 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. Senior Associate QA, International Distribution Quality What you will do We are seeking a highly motivated individual for our International Distribution Quality (IDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this relevant role. Role Description The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgen’s Global Supply Hubs to Amgen’s global markets and provide QA oversight of QA activities for Global Supply Chain operations. This role may require working in shifts or extended hours within the same shift. Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation, as well as QA triage of Distribution complaints. Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP. Expertise in quality assessment associated with transport temperature excursion management. Expertise in assessing quality impacts of distribution deviations. Hands-on experience in internal audits or self-inspections. Demonstrated experience in batch disposition and release processes. Act as subject matter expert (SME) for transportation related Quality Processes. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Collaborate with the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement Understand and incorporate risk management strategy into overall supply chain strategy Provide support for logistic service provider and transportation service provider oversight Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team Provide quality expertise and guidance to operational staff and within cross functional Amgen teams Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships. Work under minimal supervision in line with Amgen Values and Leadership Attributes Basic Qualifications: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor’s degree in science or engineering and 7+ years of professional experience in related fields. Understanding of GMP/GDP requirements. Familiarity with logistics processes of parcel, transport, and warehousing providers. Experience in Validation/Qualification of processes, equipment, and facilities. Strong technical writing skills. Preferred Qualifications: Global Supply Quality Background. Distribution Quality background. Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a “can do” outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint, Power BI and SharePoint. Ability to multi-task and prioritize 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. 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. Ready to Apply for the Job? We highly recommend utilizing Workday's robust Career Profile feature to complete the application process. A link to update your profile is available when you click Apply. You can then complete your Workday profile in minutes with the “Upload My Experience” functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile. Please note that you should be in your current position for at least 18 months before applying to internal positions. Staff must notify their current manager if invited for an interview. In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a “Partially Meets Expectations” or higher. Please visit our Internal Transfer Guidelines for more detailed information GCF Level GCF Level 04 Career Category Quality Position Type Full time .