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 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

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 escalate 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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 DisabilityAccommodations@catalent.com. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

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California Job Seekers can find our California Job Applicant Notice HERE.