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Supplier Quality Specialist / Senior Specialist (Device) - Operations

Location Gaithersburg, Maryland, United States Job ID R-085781 Date posted 07/02/2020

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 outstanding skills with those of people from all over the globe.

This position is posted as a  Supplier Quality Specialist/Senior Specialist based on experience. In this role, you will be performing supplier qualification and oversight of external medical device and combination product companies. This involves ensuring CFR 820 requirements, including Design Controls, are met for applicable CMOs.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and is only a short drive from Washington, DC. It is filled with ground breaking technology. Our lab spaces were built to facilitate collaboration, interaction and cross functional science.

We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and to keep our employees happy and balanced. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

Join AstraZeneca and help us deliver life changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in Biopharmaceuticals.

Main Responsibilities:

  • Perform supplier qualification and monitoring and associated activities (risk assessments, investigations, complaint handling, etc.) to maintain license to operate and availability of suppliers for products in the clinical portfolio
  • Operate as the AZ Quality point of contact for Contract Manufacturers (CMOs) and Contract Testing Labs (CTLs)
  • Author and negotiate Quality-based agreements or sections of agreements (ESRs, Service Level Agreements, Quality Agreement) for CMOs, Clinical trials or Inter-company/Partner relationships with no oversight
  • Working knowledge of CFRs, EuDRA and associated guidances, regulations and annexes
  • Review Design History Files (DHF) and device risk assessments
  • Provide review of master and executed batch records and support disposition of material
  • Manage and assess Supplier Initiated Changes
  • Assist in Product Complaint an Non-Conformance investigations
  • Enforcement of contractual obligations
  • Maintain computerized documentation systems
  • Provide on-site support/oversight at CMOs
  • Understand contract language and the relevance to Quality
  • Conduct of due diligence, audits and/or inspections
  • Written and oral communication across multiple levels within AZ and at external suppliers
  • Participate in continuous improvement through the use of Lean tools and principles

Minimum Requirements:

Senior QA Specialist

  • B.A. or B.S. in Biology, Biochemistry, Chemistry, Engineering or related fields
  • 3+ years of experience in Medical Device or Combination Product engineering
  • 2+ years of experience in Supplier Management

Preferred

  • Drug Product process/product development experience
  • Drug Product manufacturing experience
  • M.S. in related field

QA Specialist

  • B.A. or B.S. in Biology, Biochemistry, Chemistry, Engineering or related fields
  • 3+ years of experience in Medical Device or Combination Product engineering

Preferred

  • Supplier management experience
  • Drug Product process/product development experience
  • Drug Product manufacturing experience
  • M.S. in related field

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.



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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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.