Specialist,QualityAssurance

Specialist, Quality Assurance **Position Summary** * Shift: Monday-Friday 8am-5pm * 100% on-site Catalent’s Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site combines advanced technologies with a collaborative environment to support pharmaceutical development from early-stage formulation through commercial supply. With a strong focus on quality and innovation, the campus offers modern laboratories, state-of-the-art manufacturing suites, and specialized capabilities to meet diverse client needs. This location fosters teamwork and continuous learning, making it an excellent setting for professionals who want to contribute to delivering life-changing therapies while working in a dynamic and supportive environment. The **Specialist, Quality Assurance** performs varied work under general supervision, supporting quality assurance activities for manufacturing operations while following established protocols and work plans. The role requires attention to detail, sound judgment, and the ability to apply evaluation and problem-solving skills to ensure products are manufactured, tested, and released in compliance with FDA regulations, GXPs, and internal SOPs, while contributing to quality systems and continuous improvement initiatives. **The role:** * Perform QA support activities associated with manufacturing of pharmaceutical products * Review batch records and support product release and disposition decisions * Draft, review, and approve technical documents including SOPs and master batch records * Ensure products are manufactured, tested, and released in compliance with FDA guidelines, GXPs, and SOPs * Participate in development and maintenance of QA programs, procedures, and controls * Provide QA guidance for project outcomes and support customer interactions * Assist with manufacturing floor QA support including equipment and facility compliance * Support continuous improvement