Aseptic Officer - Specialist QA

Join Amgen’s Mission of Serving Patients At Amgen, 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. 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 QA What You Will Do In this vital role within the Plant Quality Assurance organization, the QA Specialist - Aseptic Officer, provides aseptic subject matter expertise and oversight to operational activities associated with the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under minimal supervision, the role provides compliance and aseptic oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS focused on aseptic operations. Responsibilities: Acts as the Quality organization’s main point of contact and subject matter expert for all topics related to aseptic processing. Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety. Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities. Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs. Perform impact assessments as part of change controls impacting production or QA processes. Provides quality expertise and guidance to operational staff and within cross-functional Amgen teams. Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. Participates in Amgen internal/external audits and inspections. Contribute to and drive continuous improvement projects in cross-functional collaboration. Contribute to and drive digital innovation solutions and applications in cross-functional collaboration. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a dynamic employee with these qualifications. Basic Qualifications: Doctorate degree Or Master’s degree and 2 years of quality experience Or Bachelor’s degree and 4 years of quality experience Or Associate’s degree and 8 years of quality experience Or High school diploma / GED and 10 years of quality experience Preferred Qualifications: Bachelor’s Degree in Science 5 plus years of aseptic processing experience in QA or Manufacturing Experience with leading or supporting an aseptic program for Drug Product operations Excellent interpersonal, verbal and written communication skills Experience leading and directly coaching staff to drive improved performance Strong level of analysis skills to evaluate and interpret information Experience applying problem-solving tools for root cause analysis. Strong leadership capabilities and proven experience applying GMP requirements Ability to independently interact with various levels, drives tasks to completion, and is a self-starter Applies project management principles and techniques 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 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. 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.

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