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Quality Officer/Specialist

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Sophie Steels

Sophie Steels

Job description

  • The Quality Specialist acts as the day-to-day liaison with internal and external customers for quality related activities.
  • Ensure GMP compliance of products manufactured and/or tested at a contract facility.
  • Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
  • Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
  • Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product i and GMP requirements.
  • Contribute to the completion of milestones associated with specific projects.
  • Release product in accordance with approved specifications and procedures.
  • Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Compile data and write summaries for periodic product reviews, investigations, complaints, and
  • deviations.
  • Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
  • Interact with multi-functional internal and external project teams to ensure compliance.
  • Respond to technical and quality issues and handle schedule and/or process-related conflicts.
  • Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).
  • Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
  • Provide guidance to less experienced staff, as applicable.


  • Experience in a cGxP or other regulated environment, to include
  • A few years in a Quality role
  • Excellent communication and organizational skills.
  • Demonstrated ability to perform work requiring attention to detail and of high quality

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