Senior Specialist, Quality Assurance III
Catalent · Kansas City, MO
QualityFull timeCompany career page
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Role summary
Catalent seeks a Senior Specialist in Quality Assurance III for its Kansas City facility to oversee manufacturing compliance, regulatory adherence, and product quality across oral and specialty drug delivery operations. The role involves documentation review, investigations, and cross-functional collaboration in a GMP environment.
What they're looking for
- Bachelor's or Master's degree in scientific discipline with 15+ years QA experience in GMP manufacturing
- OR high school diploma with 20+ years Quality Assurance experience in manufacturing
- 20/30 corrected vision with colorblindness testing capability
- Respirator fit testing and pulmonary physical exam clearance
- Drug Enforcement Administration screening for controlled substance handling
- Six Sigma or ASQ certification preferred
What you'll be doing
- Review and approve batch records, material documentation, labels, protocols, and quality system records for compliance
- Conduct in-process inspections, line clearances, shipment verifications, and damaged material assessments
- Lead investigations into deviations, complaints, and corrective/preventive actions using risk-based principles
- Support continuous improvement initiatives and audit readiness activities across quality programs
- Mentor junior team members and guide cross-functional collaboration on validation and commercialization projects
Privacy & handoff
This role links to Catalent's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.