Associate, Quality Assurance

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 an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans. The position supports quality oversight of manufacturing processes and ensures compliance with cGMPs, FDA, and MHRA guidelines. The successful candidate will contribute to maintaining high standards of product quality and safety while supporting continuous improvement initiatives.

Shift: M-F 6am-2:30pm

Location: Kansas City, MO

100% Onsite

The Role

• Oversee Quality support functions associated with the manufacturing of products.
• Review batch records, cleaning records, and logbooks.
• Ensure products are manufactured according to applicable current Good Manufacturing Practices (cGMPs), FDA guidelines, MHRA guidelines, regulations, and internal Standard Operating Procedures (SOPs).
• Identify deviations during manufacturing and provide direction on appropriate corrective actions.
• Review and approve batch documentation for adherence to SOPs and cGMPs.
• Participate in Quality Assurance programs, procedures, and controls to ensure products meet established standards and agency guidelines.
• Complete monthly and daily facility audits.
• Assist with manufacturing floor activities, including equipment and room approval and facility compliance.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor’s degree in a scientific discipline or at least one year of Manufacturing or Quality Assurance experience in a Good Manufacturing Practice (GMP) environment.
• Ability to follow instructions, guidance, and direction from others.
• Use existing procedures to solve routine problems.
• Apply all elements of the quality system to identify, classify, and control the status of finished products.
• Proactive in addressing work issues individually and within a team.
• Ability to follow written, oral, diagram, or schedule instructions.
• Strong mathematical and scientific reasoning skills.
• Ability to identify abnormal data and potential quality or compliance concerns and escalate to management.
• Excellent written and verbal communication skills with internal and external stakeholders.
• Lead by example in alignment with Catalent’s values and culture.
• Recognize unmet needs within the department and business.
• Collaborate effectively with peers and demonstrate leadership capabilities in a matrix environment.
• Strong time management and efficiency skills.
• Well organized with the ability to multitask.
• Work effectively under pressure to meet deadlines.
• Proficient in computer technology, including hardware and software used for common tasks (Word, Excel, Outlook, PowerPoint basics).

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• 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.

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