Senior Specialist I, Quality Assurance

Senior Specialist I, 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 a Senior Specialist I, Quality Assurance to join our team. In this role, you will support clinical trial projects and ensure compliance with regulatory requirements, good manufacturing practices and standard operating procedures. You will provide regulatory expertise for investigations and deviation management while maintaining site audit readiness. This position ensures testing methods are validated, equipment is calibrated, and results are accurate and reliable.

• Shift: Monday-Friday 8:00am-5:00pm
• Location: Kansas City, MO
• 100% Onsite

The Role

Support clinical trial projects ensuring compliance with regulatory requirements, good manufacturing practices and standard operating procedures.

Provide regulatory expertise to the investigation and deviation management process.

Participate in and maintain site audit readiness by working closely with all departments within the business unit.

Ensure testing methods are validated, equipment is calibrated, and results are accurate and reliable.

The Candidate

Minimum Requirements

Bachelor’s or Master’s degree in a scientific discipline or equivalent knowledge and experience.

5+ years of Quality Assurance experience in a Good Manufacturing Practice manufacturing environment or equivalent experience.

20/30 corrected vision exam with colorblindness testing.

Nurse assessment and pulmonary physical.

Respirator fit test.

Drug Enforcement Administration background check relating to controlled substance products.

Ability to work in refrigerator environments (35°F – 46°F / 2°C – 8°C) and/or freezer environments (-4°F / -20°C).

Ability to work near machinery and packaging equipment.

Preferred Skills & Background

Six Sigma or American Society for Quality certification preferred.

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 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 .