Senior Specialist I
24 hours ago
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.
- 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.
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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