Specialist, Quality Assurance

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 controlsProvide 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 The candidate: 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 elevate appropriately Strong organizational skills with ability to multitask and meet deadlines Ability to work collaboratively and provide guidance within a team environment Why you should join Catalent: Competitive medical benefits and 401K 152 hours PTO + 8 Paid Holidays Dynamic, fast‑paced work environment Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. #J-18808-Ljbffr