Reads, understands, and follows SOP’s and complies with cGMP. Writes and/or revises Quality documentation using 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 completed batch records, equipment logs, etc. Provides significant... more details
Quality Assurance At-the-Source Senior Specialist, Cell Therapy
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. Across our R&D and manufacturing organizations, we are investing in internal capabilities to help us realize our ambition to discover and deliver next-generation cellular therapies. 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 detailed 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.
Are you ready to champion an attitude of excellence? Join AstraZeneca's Global Quality Operations team as a Quality Assurance At-the-Source (ATS) Senior 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 significant 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 Senior 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.
Responsibilities:
- Reads, understands, and follows SOP’s and complies with cGMP.
- Writes and/or revises Quality documentation using 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 completed batch records, equipment logs, etc.
- Provides significant on-the-floor, real-time support of manufacturing operations in Grade C and Grade B environments.
- 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.
Essential Skills/Experience:
- 7+ years applicable quality experience with B.S. degree in Science, Engineering, or related technical field.
- Experience writing and investigating quality records.
- Proven track record to work in a fast-paced environment across multiple technical functions
- Strong knowledge of cGMPs.
- Demonstrated ability to make decisions that balance patient safety, compliance and supply.
Desirable Skills/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.
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.
