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Job Title: Senior Stability Specialist, Quality Control Location: Santa Monica At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 5 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to Role: AstraZeneca is seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team. The successful candidate will contribute to the advancement of our product pipeline by supporting all stability testing across multiple products and sites. The Senior Stability Specialist, is a subject matter expert responsible for coordinating stability testing, facilitating stability execution, authoring stability report, managing EDAs, and leading all investigations related to stability. This individual will work closely with the QC operation teams supporting the organizational vision. This role is based in Santa Monica, CA and reports to Manger of Quality Control. This position includes occasional weekend technical support and operates on one of the following shift, which is subject to change: Monday to Friday, 8:00AM - 4:30 PM Accountabilities: Author, review and execute Protocols and relating to Drug Product and Drug substance stability. Quality Stability Subject Matter Expert (SME) during health authority inspections, client audits, and internal reviews. Author stability protocols, summary reports, and regulatory submission documents. Assess stability data, perform statistical analyses (e.g., using Prism or JMP), and evaluate trends to determine product shelf-life and retest periods. Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical results, and stability-related deviations or CAPAs (Corrective and Preventive Actions) Coordinate sample testing with CRO, ship test materials and monitor test results. Laboratory Equipment maintenance: Schedule all PMs and repairs for QC labs Support in sample submissions, receiving, verify, store, shipment of samples, and logbook review. Perform other related duties and responsibilities as assigned. Essential Skills/Experience: PhD degree preferably in a related science field or equivalent with 0-2 years of relevant CGMP experience; OR Master’s degree preferably in a related science field or equivalent with 2-3 years of relevant CGMP experience; OR Bachelor’s preferably in a related science field or equivalent with 3-5 years of relevant CGMP experience; OR Associate’s degree preferably in a related science field or equivalent with 5-7 years of relevant CGMP experience Minimum 3 years commercial stability management Demonstrated knowledge of regulatory guidance and industry best practices Expert knowledge and understanding of stability design, execution and management of long-term, accelerated and in-use stability studies. Demonstrated knowledge leading major investigations related to stability, such as LIR, EC, OOT and OOS Must demonstrate effective organizational skills and ability to manage multiple projects. Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting and able to adjust workload based upon changing priorities. Where can I find out more? Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en Our US Footprint: Powering Scientific Innovation - YouTube The annual base pay (or hourly rate of compensation) for this position ranges from $100,786 to $151,179. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected]. Date Posted 11-Nov-2026 Closing Date 19-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca. 
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Astrazeneca
US – Santa Monica Colorado Avenue – CA, United States of America
Senior Stability Specialist, Quality Control.
SENIOR LEVEL$100.8K–151.2K/HR
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