Specialist I, Quality Assurance

Catalent; Kansas City (MO); On-site; USD 55,000 - 70,000; Full time

Job summary

Catalent's Kansas City facility is seeking a Quality Specialist I to support clinical trial projects, ensuring GMP compliance and proper documentation. This onsite role emphasizes improving quality systems, maintaining regulatory alignment, and contributing to lifecycle QA activities within a fast-paced environment.

The candidate will handle Certificate of Analysis creation under supervision, adhere to GMP standards, and perform multiple QA tasks while supporting continuous improvement

Qualifications

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

Responsibilities

• Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
• Create Certificate of Analysis with supervision. Adhere to GMP standards with guidance and create limited errors
• Support clinical trial projects ensuring compliance with regulatory requirements, good manufacturing practices and standard operating procedures.
• Implement and maintain quality assurance processes throughout the product lifecycle.
• Ensure all documentation is accurate, up-to-date and properly maintained in accordance with regulatory requirements.
• All Other Duties as Assigned.

Skills

Quality Assurance

GMP compliance

Documentation control

Regulatory awareness

Education

Bachelor’s degree in a scientific discipline

High school degree with 2+ years QA experience

Job description

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 Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure compliance with regulatory requirements, good manufacturing practices and standard operating procedures. You will maintain accurate documentation and support quality assurance processes throughout the product lifecycle. This position offers the chance to contribute to continuous improvement initiatives and develop your expertise in a dynamic environment.

Shift: Monday-Friday; 12:00pm - 8:00pm

Location: Kansas City, MO

100% Onsite

The Role

• Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
• Create Certificate of Analysis with supervision. Adhere to GMP standards with guidance and create limited errors
• Support clinical trial projects ensuring compliance with regulatory requirements, good manufacturing practices and standard operating procedures.
• Implement and maintain quality assurance processes throughout the product lifecycle.
• Ensure all documentation is accurate, up-to-date and properly maintained in accordance with regulatory requirements.
• All Other Duties as Assigned.

The Candidate

Minimum Requirements

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

Preferred Skills & Background

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

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 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 [e-mail]. 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.

California Job Seekers can find our California Job Applicant Notice HERE.