Commercial Manufacturing Quality Assurance Specialist

Catalent seeks a Commercial Manufacturing Quality Assurance Specialist to support quality operations at its Kansas City facility. The role involves batch record review, technical documentation, FDA compliance verification, and cross-functional collaboration to maintain product quality standards in a regulated manufacturing environment.

Responsibilities

• Review batch records, manage product release, and determine disposition actions
• Draft, review, and approve technical procedures and master batch records
• Ensure manufacturing and testing compliance with FDA guidelines and internal SOPs
• Develop and maintain quality assurance programs, procedures, and controls
• Support manufacturing floor activities including equipment and facility compliance verification

Requirements

• Master's degree in scientific discipline, or Bachelor's with 1+ years QA/QC/compliance experience in GMP
• Bachelor's degree in scientific discipline with 1+ years quality assurance experience in regulated environment
• Associate's degree with 3+ years FDA-regulated field experience and 1+ years QA/QC/compliance
• High school diploma with 5+ years FDA-regulated field and 1+ years QA/QC/compliance experience
• Six Sigma or American Society for Quality certification preferred
• Technical document drafting, review, and approval capability
• Knowledge of FDA guidelines, GxP regulations, and quality assurance program development