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Senior Training Specialist

10000665 - Compliance Analyst Gaithersburg, Maryland
senior training manufacturing team science technical transfer training administration learning cgmp lead collaboration
December 11, 2022
10000665 - Compliance Analyst
Gaithersburg, Maryland
FULL_TIME

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to crafting a culture of inclusion and teamwork.

The Gaithersburg site offers a variety of amenities to help boost productivity 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. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. 

Summary of the group:

The Manufacturing Transfer and Integration (MTI) team is an integral part of the overall Manufacturing Sciences group in the clinical development and manufacture of medicines within the AstraZeneca Supply Biologics organization. The MTI group supports batch record generation, investigations, tech transfer, manufacturing floor support, training administration, and various other critical functions.

Main Duties & Responsibilities:

  • Build learning content within SABA platform including courses, classes, certifications, and evaluations
  • Build out learning curriculums and required roles for various departments
  • Support various regulatory and internal audits with reports as needed
  • Administration of instructor led course completion
  • Saba Cloud technical support as needed
  • Course scheduling
  • Works in team and matrix-oriented environment with cGMP Manufacturing, Materials Management, Engineering & Automation, Technical Services, CMC Project Management, Process Development, Tech Transfer, and Quality functions.
  • Various activities as assigned

Education & Experience Requirements:

  • Bachelor’s degree
  • 2 - 5 years’ administrative experience with Bachelor’s or <2 years’ experience with Master’s
  • Experience working in a cGMP environment

Required Skills:

  • Technical writing in a cGMP setting.
  • Strong attention to detail
  • Capable of identifying areas of improvement and motivating change through lean principles
  • Strong collaborative skills to work in a team environment as well as lead their own tasks/workload for timely delivery.

Desired Skills:

  • Previous experience with Saba Cloud and/or learning plan administration a plus
  • Experience in a biotech manufacturing setting a plus
  • Ability to understand the GMP quality impact of training design
  • Able to prepare professional, technical and GMP oriented, training materials.
  • Previous experience supporting audits

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 recognising their potential. Join us on our journey of building a new kind of organisation 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.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Check out our landing page for more information on our BPD group  https://careers.astrazeneca.com/bpd

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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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