Quality Specialist I

Catalent • Kansas City, MO

2d • Onsite

About The Position

Quality Specialist I Position Summary Shift: Monday – Friday 8am-4:30pm 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements

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.
• Receives instruction, guidance and direction from others
• Uses existing procedures to solve routine problems
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Ability to work effectively under pressure to meet deadlines
• Has sufficient skills and knowledge in the use of computers and associated computer technology.

Responsibilities

• Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
• Review QC data for completeness and acceptability
• Approve Release packets with supervision
• Lead Investigator for Deviations and Complaints
• Hosting CAPA review and deviation management meetings
• Reviewing /approve change controls and change actions with supervision

Benefits

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
• Join us in making a difference. personal initiative. dynamic pace. meaningful work.

What This Job Offers

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