Senior Specialist I, Quality Assurance

Catalent•Kansas City, MO

4d•Onsite

About The Position

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. 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.

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.

Nice To Haves

Six Sigma or American Society for Quality certification preferred.

Responsibilities

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.