Catalent, Inc.

Quality Specialist I

Reposted 8 Hours Ago

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Kansas City, MO, USA

In-Office

Entry level

Biotech • Pharmaceutical

The Role

The Quality Specialist I supports clinical trial projects by ensuring compliance with regulatory requirements and maintaining quality assurance processes. Responsibilities include reviewing QC data, approving release packets, leading investigations, and participating in continuous improvement initiatives.

Summary Generated by Built In

Quality Specialist I

Position Summary

Shift: Monday – Friday 8am-4:30pm
100% on-site

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.

The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements

The role:

Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
Review QC data for completeness and acceptability
Approve Release packets with supervision
Lead Investigator for Deviations and Complaints
Hosting CAPA review and deviation management meetings
Reviewing /approve change controls and change actions with supervision

The candidate:

Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment.
Receives instruction, guidance and direction from others
Uses existing procedures to solve routine problems
Ability to identify aberrant data and potential quality/compliance concerns escalating to management
Ability to work effectively under pressure to meet deadlines
Has sufficient skills and knowledge in the use of computers and associated computer technology.

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.

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.

Skills Required

Bachelor's degree in a scientific discipline or equivalent knowledge and experience
High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment
Ability to identify aberrant data and potential quality/compliance concerns
Ability to work effectively under pressure to meet deadlines
Sufficient skills and knowledge in the use of computers and associated technology

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..

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.
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.
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.