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Quality Control Microbiology Associate Scientist

Lieu Frederick, Maryland, États-Unis Job ID R-087886 Date de publication 07/31/2020

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 facility creates life-changing medicines for people around the world. We make a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. 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. The Frederick Manufacturing Center is dedicated to creating a culture of inclusion and collaboration. We host yearly Inclusion and Diversity conferences and have an employee resource group devoted to promoting diversity and inclusion and enhancing employees' professional development through interactive and engaging events and initiatives. We are also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick, and Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019.

As a Quality Control Microbiology Associate Scientist in the Quality Control group at Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

What you’ll do

The Quality Control Microbiology Associate Scientist will be responsible for the following:

  • Non- routine laboratory support (review/SME support, testing as necessary)
  • Possessing broad instrument and theoretical knowledge of multiple Micro areas (environmental and utility monitoring, Bioburden, Endotoxin, TOC, Conductivity, Growth Promotion, Identification Testing, Stock Culture, etc.)
  • Providing technical guidance, coaching, and training for lower level personnel
  • Serving as QC interface with other functional areas including but not limited to MS&T, MFG, SCO, outside vendors
  • Writing, reviewing, and approving protocols and reports
  • Coordinating with lab managers to ensure successful execution of technical protocols,
  • Responsible for on-time delivery of new QC test method and instrument SOPs in support of tech transfer projects, and approving new QC test method and instrument SOPs.
  • Representing QC on or owning TrackWise records (Change Control, deviations, CAPA, evaluation)
  • Reviewing and approving EMIR/UIR Investigation records
  • Serving as lead investigator for non-conformance and OOS investigations of highly technical nature
  • Supporting test method and instrument troubleshooting, review of test methods, SOP review and revision, PQR and regulatory reports etc. as needed
  • Developing solutions to complex problems requiring ingenuity and creativity/innovation
  • Representing QC Micro in cross-functional projects/teams

Essential for the role:

  • Bachelor’s degree required. Scientific / Biotech / Pharmaceutical field of study
  • Advanced Degrees preferred.
  • Background in Microbiology is required.
  • 3-6 years’ experience (based on your education level) in Microbiology/Utilities/Environmental monitoring/deviations & change control is required.
  • 6 years of proven experience in related field with a Bachelors
  • 3+ years’ experience with a Master’s 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, pioneering 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 an excellent fit, please share this posting with them.

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About Operations

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.

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