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QC Analyst Frederick, MD (R-140871_Frederick)





Frederick, Maryland, United States

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 Frederick Manufacturing Center (FMC) is one of 30 production facilities in 18 countries that creates life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It’s challenging but highly rewarding work, involves more than 675 talented people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

We are dedicated to creating a culture of inclusion and collaboration. We are committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.

Why Join Quality?

In Quality, our work is meaningful and valued. An outstanding 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 perfection 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 aim to accelerate growth and make people’s lives better – then this is the place for you!

What you'll do:

Provide technical and analytical support to the Quality Control (QC) function through routine and non-routine analytical testing, instrument operation and troubleshooting, and data analysis. The individual will focus on performing analytical testing, data review, and leading projects at the QC department level. The individual should be qualified to an undergraduate level/or equivalent in a scientific field. Must have knowledge and understanding of analytical chemistry and laboratory instrumentation. Must have understanding of the QC function, and its role and importance to the business.:

  • Perform laboratory activities according to local test methods and standard operating procedures (SOPs)
  • Operate laboratory instruments for physical characterization tests (e.g. particle size analyzer, Karl Fischer oven titrator)
  • Operate chromatographic instruments and software (e.g. GC, HPLC, Empower)
  • Detail all testing activities within an electronic laboratory notebook with emphasis on ALCOA principles (attributable, legible, contemporaneous, original, accurate)
  • Utilize software to perform analytical testing, data entry, data analysis (e.g. electronic lab notebook, LIMS, SAP)
  • Supervise laboratory instrument performance and perform troubleshooting as needed
  • Author protocols, validation reports, risk assessments, trend reports, and technical justifications
  • Support and lead problem-solving activities for deviations and laboratory investigations
  • Support and lead change controls and continuous improvement initiatives

Essential for the role:

  • Bachelor of science degree, preferably in chemistry or microbiology
  • 0-5 years relevant industry or laboratory experience required
  • Experience with electronic laboratory notebooks, LIMS, Empower, SAP is preferred
  • Experience in commercial operations is preferred
  • Experience communicating with outside test laboratories (OTL)

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.

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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 authorisation and employment eligibility verification requirements.