Specialist I, Quality Assurance

Catalent seeks a Quality Assurance Specialist I for its Kansas City facility to audit laboratory data, verify compliance with pharmaceutical regulations, and support quality processes. The role requires a science degree with relevant experience or a master's degree, working onsite Monday through Friday.

Responsibilities

• Process and file quality documents including scanning, printing, and organization
• Perform laboratory data verification and audit activities
• Lead facility audits to assess compliance and operational standards
• Review and approve analytical certificates, result forms, and stability reports
• Ensure adherence to FDA and international regulatory guidelines

Requirements

• Bachelor's degree in science-related field plus 4+ years related experience, or Master's degree in science
• Strong written and verbal communication skills
• Knowledge of Good Manufacturing Practices and Good Documentation Practices
• Problem-solving ability with regulatory and standards reference capability
• Collaborative approach with ethical and inclusive conduct
• Pharmaceutical Quality Assurance or Quality Control experience preferred