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Senior Supplier Quality Specialist

2 months ago

Cincinnati, United States Germer International - Pharmaceutical Recruiting Full time

Are you looking to make the next move in your pharmaceutical career? Join our global pharmaceutical company, with approved products on the market, as the professional responsible for performing commercial Supplier Quality Management activities. This includes execution of pharmaceutical vendor audits, Quality agreements, lifecycle management, changes and complaints to external vendors. Troubleshoots issues, develops and implements effective risk mitigation strategies as required. Responsibilities include supporting daily compliance and systems activities.


This is a hybrid position (3 days onsite, 2 WFH) and requires up to 30% domestic and international travel.


Responsibilities:

  • Supplier Quality Management of commercial materials and pharmaceutical service providers
  • Lead external audits, write associated audit reports, and follow-up on actions related to audits observations
  • Evaluate change control records and manage supplier change notifications
  • Coordinate Quality Agreements both new and periodic reviews
  • Perform risk assessments and associated risk mitigation plans
  • Coordinate supplier nonconformance investigations with vendors
  • Notifies management of any atypical trend observed in the quality systems
  • Develop Standard Operating Procedures and other quality related documents
  • Review and approve written procedures and other documents
  • Interact with vendors and plant personnel to insure CGMP compliance
  • Provide support to projects, metrics and other quality systems
  • Serves as a Subject Matter Expert, and support activities in the area


Requirements:

  • BS in scientific discipline
  • 8+ years of experience in a Quality Assurance role in the pharmaceutical industry
  • Broad experience performing supplier audits


Preferred Qualifications:

  • Auditor certification preferred


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