Quality Assurance Auditor

Quality Assurance Auditor, Analytical

Position Summary

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Quality Assurance Auditor, Analytical will perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. 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 Role

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.

• Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.

• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility.

• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards.

• Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).

• Review/approve laboratory reports, COAs, stability reports in SLIM.

• Perform Gemba walks of laboratories.

• Become proficient working with SLIM, ERP System, Document Management System, TrackWise.

• Other duties as assigned.

The Candidate

• Bachelor’s degree in chemistry or related field with 3 years of professional experience in the pharmaceutical industry and 1 year in a direct QA role OR

• Associate degree in chemistry or related field with 2 years of professional experience in the pharmaceutical industry and 2 years in a direct QA role.

• Position requires the capacity to handle and manipulate objects using hands and arms.

 Why You Should Join Catalent 

• Competitive medical benefits and 401K 

• 152 hours of 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application o