AstraZeneca
Senior QA Apheresis Auditor
AstraZeneca, Gaithersburg, Maryland, us, 20883
At
AstraZeneca , we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Our
Gaithersburg, Maryland
facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 experts in our field, and it is only a short drive from Washington, DC. It is filled with cutting-edge technology. Our lab spaces were built to facilitate collaboration, interaction, and cross-functional science. We believe employees benefit from being challenged and inspired at work. We offer everything from bean bag rooms for creative brainstorming, game rooms, and Zen gardens to treadmill stations and regular campus happy hours. The Gaithersburg site offers a variety of amenities to help boost efficiency and keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center.
Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.
Why Join Quality?
In Quality, our work is important and valued. With 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 – discovery, development, and commercialization. As the voice of the patient, every batch we certify 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 Senior QA Apheresis Auditor, you will report to the Senior Quality Director and play a pivotal role in qualification and Quality oversight for the Apheresis Cryopreservation, Infusion centers, and cell supplying vendors. You’ll also contribute as part of a multidisciplinary team to develop novel cell therapies to treat diseases with Cell & Gene Therapy (CGT) as well as perform Apheresis and Infusion Site Qualifications, Audit, and Oversight.
Responsibilities:
Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers.Perform qualification and audit of cell supplying vendors.Provide Quality oversight to Apheresis, Cryopreservation, and infusion centers.Facilitate quality agreements.Participate and provide support to deviations, CAPAs, OOS, change controls, and product complaints involving Apheresis and Infusion centers and cell supplying vendors.Liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality-related issues.Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.Audit readiness support for regulatory inspections queries related to Apheresis/Cryopreservation/infusion vendors.Build and maintain strong customer relationships with other functions whose activities overlap, influence, or affect compliance and lead or participate in GxP audits/initiatives with other AZ Quality groups.
Qualifications And Experience
Essential:
Bachelor's Degree and Minimum 7 years’ experience working in GMP Quality with direct experience in compliance and auditing.15+ years of applicable experience with an Associate's Degree.20+ years of applicable experience with a High School Diploma.Knowledge of CGT products for clinical use in humans.Desirable:
A broad and comprehensive understanding of investigational medicinal products.Experience in auditing and qualification of Apheresis/Infusion centers or Cryopreservation centers for CGT products.Advanced degree.
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.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Find out more on Social Media:
LinkedIn:
https://www.linkedin.com/company/1603/Facebook:
https://www.facebook.com/astrazenecacareers/Instagram:
https://www.instagram.com/astrazeneca/?hl=enAbout Operations:
https://www.youtube.com/watch?v=gak5Ham8oUw
#J-18808-Ljbffr
AstraZeneca , we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Our
Gaithersburg, Maryland
facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 experts in our field, and it is only a short drive from Washington, DC. It is filled with cutting-edge technology. Our lab spaces were built to facilitate collaboration, interaction, and cross-functional science. We believe employees benefit from being challenged and inspired at work. We offer everything from bean bag rooms for creative brainstorming, game rooms, and Zen gardens to treadmill stations and regular campus happy hours. The Gaithersburg site offers a variety of amenities to help boost efficiency and keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria, and copy center.
Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.
Why Join Quality?
In Quality, our work is important and valued. With 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 – discovery, development, and commercialization. As the voice of the patient, every batch we certify 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 Senior QA Apheresis Auditor, you will report to the Senior Quality Director and play a pivotal role in qualification and Quality oversight for the Apheresis Cryopreservation, Infusion centers, and cell supplying vendors. You’ll also contribute as part of a multidisciplinary team to develop novel cell therapies to treat diseases with Cell & Gene Therapy (CGT) as well as perform Apheresis and Infusion Site Qualifications, Audit, and Oversight.
Responsibilities:
Perform audit and site qualifications of Apheresis, Cryopreservation, and infusion centers.Perform qualification and audit of cell supplying vendors.Provide Quality oversight to Apheresis, Cryopreservation, and infusion centers.Facilitate quality agreements.Participate and provide support to deviations, CAPAs, OOS, change controls, and product complaints involving Apheresis and Infusion centers and cell supplying vendors.Liaison between Manufacturing site Quality and Apheresis/Cryopreservation centers on quality-related issues.Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.Audit readiness support for regulatory inspections queries related to Apheresis/Cryopreservation/infusion vendors.Build and maintain strong customer relationships with other functions whose activities overlap, influence, or affect compliance and lead or participate in GxP audits/initiatives with other AZ Quality groups.
Qualifications And Experience
Essential:
Bachelor's Degree and Minimum 7 years’ experience working in GMP Quality with direct experience in compliance and auditing.15+ years of applicable experience with an Associate's Degree.20+ years of applicable experience with a High School Diploma.Knowledge of CGT products for clinical use in humans.Desirable:
A broad and comprehensive understanding of investigational medicinal products.Experience in auditing and qualification of Apheresis/Infusion centers or Cryopreservation centers for CGT products.Advanced degree.
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.
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Find out more on Social Media:
LinkedIn:
https://www.linkedin.com/company/1603/Facebook:
https://www.facebook.com/astrazenecacareers/Instagram:
https://www.instagram.com/astrazeneca/?hl=enAbout Operations:
https://www.youtube.com/watch?v=gak5Ham8oUw
#J-18808-Ljbffr