Include reading, understanding, and following SOP’s and aligning with cGMP, writing and/or revising Quality documentation applying electronic document management systems, supporting the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents, supporting the issuance and reconciliation of cGMP documentation, reviewing and/or approving completed batch records, equipment logs,... more details
About Cell Therapy:
In Operations, we turn molecules into medicine and are unified in our commitment to deliver more medicines to more patients more quickly. In essence, we are the critical link that brings innovation from our science labs to patients around the world. From our quality labs to commercial manufacturing, we share a common purpose to ensure our high-quality medicines reach patients when and where they need them, with the ultimate goal of improving their daily lives. We’re achieving all of this while continuing to accelerate our operational excellence through innovative science, Lean ways of working, and evolving digital technologies.
Using cell therapy to halt and reverse disease, restore damaged organs, and, ultimately, cure many life-threatening conditions is now a realistic goal for our scientists and operators. Demonstrating institutional expertise in biologics engineering, gene editing and immunology, we are uniquely positioned to develop innovative technologies to advance cell therapies in the treatment of disease areas with high unmet medical needs.
About Rockville Manufacturing Center (RMC):
Our role in Operations is to bring these promising therapies from the lab to life through a thorough process of development, manufacturing, testing and supply. Our fast-paced, growing environment provides a wealth of opportunity and global opportunities to learn from other teams, adopt lifelong learning and build capabilities, setting your own direction and pace for your long-term career. Our Rockville Manufacturing Center (RMC) cell therapy facility located in Rockville, Maryland is the newest addition to our global supply network of nearly 30 manufacturing and supply facilities in 16 countries. This manufacturing facility aims to make a direct contribution and immediate impact to patients by delivering life-saving cell therapies. It’s exciting and highly rewarding work, involving hundreds of dedicated people throughout the manufacturing lifecycle along with supporting office functions. Every day at AstraZeneca we work hard to deliver life-changing medicines to patients, along with taking time to have fun and celebrate our accomplishments. From catered site festivities to driven events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.
Introduction to the Role:
Are you ready to develop an attitude of excellence? Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) Specialist, Cell Therapy at the Rockville Manufacturing Center (RMC) facility, the newest addition to our global supply network. We aim to make a direct impact on patients by delivering life-saving cell therapies. This is your chance to break new ground and leave a collective legacy! We are investing in internal capabilities across our R&D and manufacturing organizations to help us realize our ambition to discover and deliver next-generation cellular therapies.
Why Join Quality?
In Quality, our work is important and valued. An unrivalled forward-looking mentality, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. As the voice of the patient, every batch we work on is a personal stamp of approval. Not something we take lightly, we are always innovating, trailing the latest models and technologies to improve reliability and excellence in our processes. A place to take Quality seriously – we draw findings from others, to develop and understand what it takes to drive our modern mindset forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first. If you have the passion and the aim to accelerate growth and make people’s lives better – then this is the place for you.
What you’ll do:
As a QA ATS Specialist, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The individual assures the quality and compliance for commercial and clinical products manufactured at the facility.
Accountabilities:
Responsibilities include reading, understanding, and following SOP’s and aligning with cGMP, writing and/or revising Quality documentation applying electronic document management systems, supporting the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents, supporting the issuance and reconciliation of cGMP documentation, reviewing and/or approving completed batch records, equipment logs, etc., providing significant on-the-floor, real-time support of manufacturing operations in Grade C and Grade B environments, supporting internal audits of manufacturing, analytical testing, labeling, etc. to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program, supporting continuous improvement efforts and participating in cross-functional Tier meetings. You must have the ability to work "off-hours" as needed to support release of product to meet patient dosing needs.
Essential Skills/Experience:
- 5+ years applicable quality experience with B.S. degree in Science, Engineering or related technical field.
- Proven ability to work in a fast-paced environment across multiple technical functions.
- Strong knowledge of cGMPs.
- Demonstrated ability to make decisions under pressure that balance patient safety, compliance and supply.
Desired Skills/Experience:
- Autologous cell therapy manufacturing or quality experience.
- Working knowledge of international Cell Therapy GxP regulatory frameworks, regulations and guidance.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking cutting-edge methods and bringing unexpected teams together. Interested? Come and join our journey.
At AstraZeneca, we are leading our Operations function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mentality and sustainable practices. Every change we make is to deliver better outcomes for our patients. We are the champions of Lean, ensuring our teams understand and embody the benefits it can bring. There's improved quality and safety, as well as speed. Our manufacturing sites are environments of constant and rapid change. It's a place to expect the unexpected. There's rarely an obvious answer to the varied challenges we face, so it takes adaptability, flexibility and perseverance to thrive here.
Ready to join us on this exciting journey? Apply now!
Date Posted
24-Jun-2024
Closing Date
18-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
