Specialist I, Quality Assurance

Catalent Pharma Solutions • Kansas City, MO

4d • Onsite

About The Position

Catalent’s Kansas City facility supports Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. The Quality Specialist I supports clinical trial projects by helping ensure compliance with regulatory requirements, good manufacturing practices (GMP), and standard operating procedures (SOPs). The role maintains accurate documentation and supports quality assurance processes throughout the product lifecycle, while contributing to continuous improvement initiatives and developing quality expertise.

This position is 100% onsite in Kansas City, Missouri, with a Monday–Friday shift from 12:00 p.m. to 8:00 p.m. The specialist creates Certificates of Analysis with supervision, follows GMP standards with guidance, and supports quality processes and documentation. The role may involve working in refrigerated or freezer environments and near machinery and packaging equipment.

Requirements

• Bachelor’s degree in a scientific discipline, or equivalent knowledge and experience.
• High school degree and at least 2 years of Quality Assurance experience in a GMP manufacturing environment.
• Pass a 20/30 corrected vision exam with colorblindness testing.
• Complete a nurse assessment and pulmonary physical.
• Pass a respirator fit test.
• Complete a DEA background check relating to controlled substance products.
• Ability to work in refrigerator environments of 35°F–46°F (2°C–8°C) and/or freezer environments of -4°F (-20°C).
• Ability to work near machinery and packaging equipment.

Nice To Haves

• Ability to identify aberrant data and potential quality or compliance concerns and escalate them to management.
• Ability to work effectively under pressure to meet deadlines.

Responsibilities

• Participate in continuous improvement initiatives to enhance quality management processes, systems, and procedures.
• Create Certificates of Analysis with supervision and adhere to GMP standards with guidance while minimizing errors.
• Support clinical trial projects to ensure compliance with regulatory requirements, GMP, and SOPs.
• Implement and maintain quality assurance processes throughout the product lifecycle.
• Ensure documentation is accurate, up to date, and properly maintained in accordance with regulatory requirements.
• Perform other duties as assigned.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Competitive paid time off and 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level