Specialist, Quality Assurance
About The Position
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.
Requirements
- Master’s degree in a scientific discipline, OR Bachelor’s degree with 3+ years of QA experience, OR High School Diploma with 10+ years of pharmaceutical experience and 3+ years in QA
- Experience in a GMP manufacturing environment
- Knowledge of FDA regulations, GXPs, and quality systems
- Experience with batch record review, product release, and QA oversight
- Experience drafting/reviewing SOPs, batch records, and technical documents
- Strong written and verbal communication skills
- Ability to identify quality/compliance issues and escalate appropriately
- Strong organizational skills with ability to multitask and meet deadlines
- Ability to work collaboratively and provide guidance within a team environment
Responsibilities
- 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 initiatives and annual product review activities
Benefits
- Competitive medical benefits
- 401K
- 152 hours PTO
- + 8 Paid Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
