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Quality Systems Specialist II - Training

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Gaithersburg, MD

Employer:  AstraZeneca
Job Type:  Full Time

Description

We are seeking a highly organized and detail-oriented Quality Systems Specialist II - Training to join our team. The ideal candidate will be responsible for various quality and documentation accountabilities, including training support, documentation management, quality systems support, and more. The role will require close collaboration with internal teams, and the ability to ensure compliance with current good manufacturing practice regulations.

What you will do:

Training Accountabilities:
  • Provide support for the GxP training function in a pharmaceutical manufacturing environment.
  • Assist in designing, developing, and delivering training and educational programs.
  • Maintenance of training records.

Documentation Accountabilities:
  • Maintain document tracking system and issue/track document distribution.
  • Review and approval of GXP documentation within EDMS System(s).
  • Issue controlled documents such as batch records, forms, and protocol numbers.
  • Support archive users by performing database searches, file retrieval, and photocopying as needed.

Quality Systems Support:
  • Assist in managing Quality records, including Change Controls, Deviations, Product Complaints, and CAPAs.
  • Support the application of the AZ Quality System and participate in lean initiatives to improve business operations.
  • Utilize quality assurance systems in compliance with current good manufacturing practice regulations
  • Perform edit, review, and approval of GxP-controlled documentation.
  • Maintain document archive via EDMS System and storage of hard copy documents.
  • Standardize and simplify the GMP document review process.
  • Provide documentation support for internal and external audits/inspections.

Minimum Qualifications:
  • Degree in Biology, Chemistry, Engineering, or related fields, or equivalent experience.
  • Minimum 3 years of industry experience.
  • Attention to detail and time management skills.
  • Proficiency in Outlook, Electronic Document Management Systems, and Microsoft Office Applications including SharePoint.

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $76,412.80 to $114,619.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, the employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

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.
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