About Site
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.
Position Summary
We have an opportunity for a Specialist I, Quality Assurance to join our team. In this role, you will focus on auditing laboratory data to ensure compliance with procedures and regulations in the pharmaceutical industry. You will review critical documentation and support quality processes to maintain high standards. This position plays a key role in ensuring adherence to Good Manufacturing Practices and regulatory guidelines.
Shift: M-F 8am-5pm
Location: Kansas City, MO
100% Onsite
The Role
- Process documents submitted to Quality, including scanning, printing, and filing
- Perform laboratory data verification and data audits
- Lead laboratory facility audits
- Review and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability Protocols
- Follow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelines
- Perform all other duties as assigned
The Candidate
Minimum Requirements
- Bachelor’s degree in a science-related field and 4+ years of related work experience, or Master’s degree in a science-related field with no experience required
- Clear communicator in written and verbal form; seeks answers from standards and regulations and escalates when needed
- Demonstrates Catalent Leadership Competencies at the Individual level: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops
- Responds to problems and identifies solutions; develops methods to address constraints and waits for approval before implementation
- Collaborates effectively with others; handles conflict constructively and communicates necessary information
- Builds trust by acting ethically and inclusively; ensures compliance with regulations, policies, and standards; raises questions or concerns when needed
Preferred Skills & Background
- Veterinary or Human Pharmaceutical Quality Assurance or Quality Control experience strongly preferred
Why You Should Join Catalent
- Defined career path with annual performance reviews and feedback
- Diverse and inclusive culture
- Opportunities for career growth within an organization dedicated to improving lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective on day one
- Tuition reimbursement
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.
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 [email protected]. 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:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
Skills Required
- Bachelor's degree in a science-related field and 4 or more years of related work experience, or a master's degree in a science-related field with no experience required.
- Clear written and verbal communication skills.
- Ability to interpret standards and regulations and escalate issues when needed.
- Ability to identify solutions and develop methods to address constraints, pending approval before implementation.
- Ability to collaborate effectively, handle conflict constructively, and communicate necessary information.
- Ability to ensure compliance with regulations, policies, and standards.
- Veterinary or human pharmaceutical Quality Assurance or Quality Control experience.
Catalent, Inc. Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Catalent, Inc. and has not been reviewed or approved by Catalent, Inc..
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Leave & Time Off Breadth — Paid time off is commonly described as roughly 152 hours per year plus about eight paid holidays for U.S. roles. Eligibility and exact counts vary by location, but the allotment is positioned as competitive.
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Retirement Support — A 401(k) with a company match (often described as dollar‑for‑dollar up to 6%) is part of the package. The match level is commonly referenced as a meaningful component of total rewards.
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Inclusive Benefits Coverage — Medical, dental, vision, life/disability, HSA/FSA, EAP, tuition reimbursement, adoption assistance, commuter and dependent‑care benefits, and wellness programs are offered. Some roles indicate benefits eligibility begins on the first day for direct hires.
Catalent, Inc. Insights
What We Do
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.
