Quality Assurance Specialist
7 hours ago
Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a Quality Assurance Specialist to join our team in Kansas City, MO.
Job Summary:The Quality Assurance Specialist will be responsible for ensuring the quality and compliance of our products. This includes reviewing production logbooks for GMP compliance, revising SOPs as needed, and ensuring that products are manufactured, packaged, tested, and released according to applicable FDA guidelines and internal SOPs.
Key Responsibilities:- Review production logbooks for GMP compliance and revise SOPs as needed
- Ensure that products are manufactured, packaged, tested, and released according to applicable FDA guidelines and internal SOPs
- Participate in QA programs, procedures, and controls to ensure that products conform to established standards and agency guidelines
- Assist with packaging floor activities for primary and secondary operations
- Follow all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
- Respond and interact with internal and external clients in a professional and timely manner
- A high school diploma/GED is required with a minimum of 10 years of QA experience in a GMP manufacturing environment
- We will also accept a Bachelor's degree in a scientific discipline with 3+ years of experience, or a Master's degree in a scientific discipline with no experience
- Six Sigma or ASQ certification preferred
- Experience with Trackwise, JD Edwards, EDMS (Electronic Document Management System), and SharePoint preferred
Catalent offers a dynamic and fast-paced work environment, a diverse and inclusive culture, and a commitment to patient safety and quality. We provide a competitive salary, 152 hours of PTO, and a generous 401K match. We also offer tuition reimbursement, a well-hub program for overall physical wellness, and a perkspot program with exclusive discounts.
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, please submit your request by sending an email to .
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