Senior Specialist I

24 hours ago


Madison, Wisconsin, United States Catalent Inc Full time
About the Role

Catalent Inc is seeking a highly skilled Senior Specialist I - Quality Assurance to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with regulatory requirements and internal quality systems.

Key Responsibilities
  • Maintain and enhance the effectiveness of the Quality System through compliant preparation and execution of production.
  • Represent Quality Assurance as the primary contact for assigned projects, collaborating with internal and external stakeholders to ensure effective management of client expectations.
  • Interface with clients and manage internal communication to sustain and enhance client quality relationships.
  • Review and approve project-related documents, including Master Batch Production Records and technical transfer reports.
  • Ensure that Finished Products are manufactured and tested in accordance with regulatory or client requirements.
  • Finalize approval and disposition of finished product for shipment to customers.
  • Develop and provide training to support the training program for QA and manufacturing on specific quality functions.
  • Drive alignment and improvement initiatives, leading cross-functional teams to address process improvement, system improvement, and new regulations.
  • Act as the quality contact and Subject Matter Expert (SME) for Quality Assurance operations and Quality management of client programs.
  • Provide program-specific review of documents supporting process validation and regulatory filings.
  • Lead continuous improvement projects for the Quality Assurance Operations department.
Requirements
  • Doctorate Degree in a STEM discipline with a minimum of 7 years of related experience.
  • OR Master's Degree in a STEM discipline with a minimum of 10 years of related experience.
  • OR Bachelor's Degree in a STEM discipline with a minimum of 15 years of related experience.
  • OR Associate's Degree in a STEM discipline with a minimum of 17 years of related experience.
About Catalent Inc

Catalent Inc is a global leader in the development and delivery of pharmaceuticals, biologics, and consumer health products. We are committed to preserving and bettering lives through our innovative technologies and solutions.



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