Quality Assurance At-the-Source Lead, Cell Therapy

Quality Assurance At-the-Source Lead, Cell Therapy 

 Are you ready to foster an attitude of excellence? Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) Lead, 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 mindset, 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 learnings 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 drive to accelerate growth and make people’s lives better – then this is the place for you. 

What you’ll do:  

As a QA ATS Lead, 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. 

Responsibilities:  

• Supports team members by facilitating scheduling and personnel coordination, removing roadblocks and mentoring in complex situations.  

• Reads, understands, and follows SOP’s and complies with cGMP 

• Writes and/or revises Quality documentation utilizing electronic document management systems 

• Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents 

• Supports the issuance and reconciliation of cGMP documentation 

• Reviews and/or approves executed batch records, equipment logs, etc. 

• Supports internal audits of manufacturing, analytical testing, labeling, etc. to ensure compliance with SOPs and regulatory requirements per the requirements of the self-inspection program 

• Supports continuous improvement efforts 

• Participates in cross-functional Tier meetings 

• Ability to work "off-hours" as needed to support release of product to meet patient dosing needs 

• Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in the Electronic Quality System 

• Assists with deviation investigation and root cause analysis 

QA ATS Lead Required Education and Experience:  

• 7+ years applicable quality experience with B.S. degree in Science, Engineering, or related technical field 

• 11+ years applicable with Associates degree 

• 15+ years applicable with High School Diploma 

• Experience writing and investigating quality records 

• 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   

Preferred Experience: 

• M.S degree in Science, Engineering or related technical field 

• 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.