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Supplier Quality Specialist/ Senior Specialist - Operations

Местоположение Гейтерсберг, Мэриленд, США Идентификатор вакансии R-067232 Дата публикации 12/02/2019

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.

**This position is posted as a Specialist/Senior Specialist based on experience**

Essential Job Functions:

  • Prior experience in external quality relationships
  • Skilled in performing supplier qualification and monitoring process and associated activities (risk assessments, investigations, complaint handling, etc.) to maintain license to operate and availability of suppliers for projects. This encompasses routine and non-routine suppliers.
  • Experience providing customer support regarding the external quality function and system
  • Ability to 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
  • Comfortable with contract language
  • Technical expert in at least one area of manufacturing (cell banking, drug substance, API, drug product or pack and label)
  • Working knowledge of CFRs, EuDRA and associated guidances, regulations and annexes
  • Understanding of QP release process and assurances required by supplier quality
  • Has prior exposure with multiple CMO quality systems for various manufacturing capabilities
  • Expert in assessment of Supplier Initiated Changes for any changes at suppliers
  • Ability to conduct Product Complaint investigations utilizing expertise with systems and processes
  • Comfortable with difficult conversations and ambiguous situations, internally and externally
  • Experience in parsing and enforcing contractual obligations
  • Maintain computerized documentation systems
  • Experience in supplier KPIs
  • Prior experience in the conduct of due diligence/audits/inspections
  • Experience to author quality procedures and presentations
  • Ability to represent the department on project teams and routine meetings
  • Prior experience with Lean or other tools for continuous improvement
  • Can demonstrate timely decision making with little oversight
  • Should possess strong communication skills, both verbally and written.

Minimum Requirements:

  • 3-4 years experience in at least one of the following areas of manufacturing: cell banking, drug substance, API, drug product or pack and label
  • 2+ years of supplier quality experience (for the Specialist)
  • 5+ years of supplier quality experience  (for the Senior Specialist)

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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