Quality Assurance Specialist I – GMP & Clinical Trials

Regulatory Toolkit; Kansas City (MO); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Medical, dental and vision benefits on

Tuition reimbursement

Paid time off + 8 holidays

Job summary

Catalent is seeking a Quality Assurance Specialist I for our Kansas City, MO site to support clinical trial projects and ensure compliance with GMP and regulatory requirements. You will maintain accurate documentation and contribute to quality assurance processes across the product lifecycle in a 12:00pm–8:00pm shift, onsite.

Responsibilities include participating in continuous improvements, preparing Certificates of Analysis, and ensuring timely, compliant records and procedures.

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

Documentation

Regulatory compliance

Continuous improvement

Education

Bachelor’s degree in a scientific discipline

Job description

Catalent is seeking a Quality Assurance Specialist I for our Kansas City, MO site to support clinical trial projects and ensure compliance with GMP and regulatory requirements. You will maintain accurate documentation and contribute to quality assurance processes across the product lifecycle in a 12:00pm–8:00pm shift, onsite.

Responsibilities include participating in continuous improvements, preparing Certificates of Analysis, and ensuring timely, compliant records and procedures.