Quality Control Scientist

AstraZeneca Frederick, Maryland
quality control people manufacturing analytical operations patients transfer team learning growth technical regulatory r&r
October 7, 2022
AstraZeneca
Frederick, Maryland
FULL_TIME

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.


Everything we do is to make people’s lives better. To us it’s personal, as we invent, make, deliver and support. Taking our cutting-edge innovations from our science labs to patients. Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to shape the next phase of Operations’ evolution and growth. We explore, willing to support new ideas, go above and beyond to find better solutions, every day. This is a place for the resilient – hungry for new challenges and diverse opportunities. The driven – willing to learn, take personal accountability and step out of their comfort zone. To build a collective legacy of doing good for people, the environment and society.


Why Join Operations?


Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.


If you have the passion and the drive to accelerate growth and make people’s lives better – then this is the place for you.


As a Quality Control Scientist in Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.


What you’ll do:

  • Responsible for performing laboratory support functions that are complex and technically demanding within the area/field of QC.

  • Conducts or participates in multiple simultaneous projects that are complex and technically demanding within the area/field of QC.

  • Initiates, implements, plans, directs, and executes investigations to resolve deviations, understand analytical trends, and/or improve process performance.

  • Responsible for balancing day-to-day technical support for QC labs and longer term projects or investigations.

  • Assumes leadership responsibility for analytical tech transfer programs, operating as receiving and/or sending unit.

  • Facilitates global analytical tech transfer programs, accommodating country-specific requirements to ensure successful transfer.

  • Responsible for maintaining technical expertise on several analytical areas and instrumentation (eg, HPLC, ELISA, BioAssay, electrophoretic assays) as assigned.

  • Possesses working knowledge on process unit operations within a section of the manufacturing process (either upstream, downstream, or fill/pack) as assigned.

  • Works under general supervision of higher-level scientist or manager.

  • Responsible for writing/reviewing sections of regulatory documents.

  • Maintains up to date familiarity with applicable regulations and regulatory guidance associated with analytical method design/transfer/validation requirements.

  • Serves as subject matter expert for various analytical themes on behalf of QC, routinely engaging with regulatory agencies during inspections.

  • Generally, indirectly supervise lower-level associates.

  • Provides solutions to a wide range of difficult problems, which requires creative thinking.

  • Solutions are imaginative, thorough, and practicable.

  • Decisions or recommendations consistently result in project advancement and favorable budget outcomes.

  • Conducts independent research, development or support programs.

  • May generate internal or external documents of value to the company.

  • May be a contributing member of one or more project teams.

  • Accomplishes tasks mainly as an individual contributor, but also provides technical guidance to less experienced staff. May direct activities of lower-level staff. Leads project teams.


Education/Experience:


  • Bachelor’s Degree in scientific/biotech/pharmaceutical field of study Preferred 8+ yrs of pharmaceutical or biopharmaceutical industry.

  • Master’s degree in scientific/biotech/pharmaceutical field of study. Preferred 4+yrs of pharmaceutical or biopharmaceutical industry.

  • PhD: Scientific/biotech/pharmaceutical field of study. Preferred 2+yrs of pharmaceutical or biopharmaceutical industry.


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 a phenomenal 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


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