Quality Specialist

Are you passionate about ensuring the highest level of quality in pharmaceutical products? Do you have a keen eye for detail and a strong understanding of regulatory requirements? If so, we have an exciting opportunity for you to join our team as a Quality Specialist at Catalent. As a global leader in drug development and delivery solutions, Catalent is dedicated to improving the lives of patients around the world. We are seeking a highly skilled and motivated individual to support our quality assurance efforts and contribute to our mission of delivering safe and effective medicines. If you possess the necessary qualifications and a drive for excellence, we encourage you to apply for this role and become a part of our dynamic and innovative organization.

1. Develop, implement, and maintain quality assurance processes and procedures in compliance with regulatory requirements and industry standards.
2. Conduct regular inspections and reviews of manufacturing processes, facilities, and equipment to ensure compliance with quality standards.
3. Perform thorough investigations and root cause analysis for any quality issues or deviations.
4. Review and approve batch records, analytical data, and other related documents to ensure accuracy and compliance.
5. Collaborate with cross-functional teams to identify and address quality issues and implement corrective and preventative actions.
6. Stay informed of changes in regulatory requirements and industry trends and incorporate them into quality assurance processes.
7. Train and educate employees on quality standards, procedures, and regulations.
8. Conduct internal audits to assess compliance with quality systems and identify areas for improvement.
9. Participate in external audits and inspections by regulatory agencies or clients.
10. Implement and maintain a quality management system to ensure continuous improvement and adherence to quality standards.
11. Communicate and report quality metrics and trends to management and make recommendations for improvement.
12. Participate in the development and validation of analytical methods and testing procedures.
13. Assist in the review and approval of product specifications and batch records.
14. Maintain accurate and organized quality records and documentation.
15. Support and participate in quality-related projects or initiatives as needed.

According to JobzMall, the average salary range for a Quality Specialist in Greendale, IN 47025, USA is $45,000-$70,000 per year. This may vary depending on the specific industry and company, as well as the individual's experience and qualifications. Other factors that can affect salary include geographic location, job responsibilities, and company size.

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.