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Quality Assurance Specialist IV Cell and Gene Therapy - Gaithersburg, MD

Location Gaithersburg, Maryland, United States Job ID R-157507 Date posted 23/01/2023

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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 labs 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 brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help 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. 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 Quality Assurance Specialist II / III, 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 of testing for commercial and clinical products manufactured at the facility.

Responsibilities:

Performs selected quality assurance activities, dependent upon assigned area, including the following:

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

Writes new standard operating procedures or revises existing documentation utilizing 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 GMP documentation

Electronic system usage with tools such as Trackwise, GQCLIMS, Pas-X and SAP

Reviews documented information from their functional area, reports abnormalities

Creates/revises QA documents (SOPs, technical reports, risk assessments) in document management system.

Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in QIMS.

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

Facilitates and coordinates training of new and existing team members, prepares training materials as necessary.

Quality Assurance Specialist II

  • Bachelor’s degree; biology, chemistry or science-related field preferred
  • 3+ years of proven experience
  • Cell and Gene Therapy Manufacturing Experience and/or Knowledge preferred
  • Project Management Skills

Quality Assurance Specialist III

  • Bachelor's degree; biology, engineering or science-related field preferred
  • 5+ year of proven experience
  • 3+ years of demonstrated ability in QA preferred
  • Cell and Gene Therapy Manufacturing Experience and/or Knowledge preferred
  • Project Management Skills

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=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.