Quality Assurance Associate

AstraZeneca • Santa Monica, CA

6d • $65,557 - $98,335 • Hybrid

About The Position

AstraZeneca is seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team. The successful candidate will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks. You will also be expected to independently organize and manage timelines for batch record reviews. You will be expected to provide support for both the Santa Monica, CA and Tarzana, CA sites as needed.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

At AstraZeneca, we follow the science and pioneer new frontiers. Our team is dedicated to Oncology with a vision to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration, empowering you to lead at every level and take smart risks that drive patient outcomes. Ready to make a difference? Apply now and join us on this exciting journey!

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.

Requirements

• BA/BS in Biology, Chemistry, Microbiology, Engineering, or a related field is required (no prior work experience needed). Alternatively, an Associate’s degree with up to 2 years of relevant experience or a High School diploma with up to 4 years of relevant experience is required.
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
• Attention to detail and quick learning/application of concepts and information.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.

Nice To Haves

• Relevant academic laboratory experience, coursework, or internships are a plus.
• Flexibility of occasionally working in weekend or holidays to support lot release.
• Experience in Cell or Gene Therapy
• Well versed in various cell therapy manufacturing processes

Responsibilities

• Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Work with Doc Control to ensure archival of batch records.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media records and labels) to manufacturing.
• Provide quality assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within AZ to assure compliance with the quality manual and maintain collaborative quality relationships.
• Perform other duties as requested by supervisor/manager to support Quality.
• Administrative Tracking of QA metrics
• On the Floor QA support

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level