Senior Specialist I, Quality Assurance
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
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.
