Senior Specialist, Quality Assurance III

About the role

Catalent’s Kansas City facility houses Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses. This position offers the chance to collaborate with cross‑functional teams and provide guidance to ensure product quality and compliance.

Responsibilities

• Ensure products are manufactured, packaged, tested, released, and shipped in compliance with quality standards, Good Manufacturing Practices, company procedures, and regulatory requirements.
• Perform quality review and approval of batch records, material release documentation, labels, protocols, validation documents, change controls, and other quality system documentation.
• Conduct in‑process production inspections, line clearances, shipment verifications, damaged material assessments, annual retain inspections, and label control activities.
• Lead and support investigations for deviations, complaints, protocol deviations, and corrective and preventive actions, ensuring timely resolution using risk‑based quality principles.
• Participate in continuous improvement initiatives, process enhancements, audit readiness activities, and the development and maintenance of Quality Assurance programs, procedures, and controls.
• Develop and execute work plans and schedules; mentor junior team members; provide Quality Assurance guidance to support project execution, commercialization activities, and customer interactions.
• Collaborate with cross‑functional teams and clients to support validation, data integrity, quality review meetings, equipment qualification, and compliance with established standards and regulatory agency guidelines.
• Perform other duties as assigned.

Requirements

• Bachelor’s or Master’s degree in a scientific discipline with 15+ years of Quality Assurance experience in a Good Manufacturing Practice environment, or equivalent industry experience.
• Or high school diploma with 20+ years of Quality Assurance experience.
• 20/30 corrected vision exam with color‑blindness testing.
• Respirator fit testing and pulmonary physical.
• Drug Enforcement Administration screening for controlled‑substance product.

Preferred Skills

• Six Sigma or American Society for Quality certification preferred.

Benefits

• Defined career path with annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Competitive paid time off plus eight paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Schedule

Standard hours, Monday through Friday. Location: Kansas City, MO – 100% onsite.