Senior Specialist I

3 weeks ago


Madison, Wisconsin, United States Catalent Inc Full time
Job Title: Senior Specialist I

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.

Job Summary:

The Quality Assurance department is responsible for ensuring compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition.

Key Responsibilities:
  • Maintain and enhance the effectiveness of the Quality System through ensuring compliant preparation and execution of production.
  • Represent Quality Assurance as the primary contact for assigned projects, which includes cross-functional internal and external collaboration, supporting integration of the client programs into the Catalent Quality Management System and ensuring effective management of client expectations.
  • Interface with clients and manage internal communication to sustain and enhance the Client quality.
  • Review and approve project-related documents such as Master Batch Production Records, technical transfer and process characterization reports.
  • Ensure that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
  • Final approval and disposition of finished product for shipment to customers.
  • Maintain a high level of understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems.
  • 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.
Requirements:
  • Doctorate Degree in STEM discipline with minimum of 7 years related experience, or Master's Degree in STEM discipline with minimum of 10 years related experience, or Bachelor's Degree in STEM discipline with minimum of 15 years related experience, or Associate's Degree in STEM discipline with minimum of 17 years related experience.
Benefits:
  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 hours of paid time off annually + 8 paid holidays.
  • Competitive salary with yearly bonus potential.
  • Community engagement and green initiatives.
  • Generous 401K match and Paid Time Off accrual.
  • Medical, dental and vision benefits effective day one of employment.
  • Tuition Reimbursement.

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