Quality Assurance Specialist

Quality Assurance Specialist

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 Specialist position requires the ability 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. The Quality Assurance Specialist will provide broad advocacy for the continued improvement of quality standards and the development and

maintenance of a quality culture across the organization.

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

• 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).

• Provide assistance to laboratories with appropriate quality oversight.

• Escalate unplanned events and issues, providing immediate notification to QA Management, supporting and providing guidance to laboratory staff as assigned.

• Review Quality documentation including but not limited to review of laboratory reports, CoAs, methods, specifications, method validation protocols and method validation reports.

• Remain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues.

• Act as QA representative on project teams, providing Quality guidance and support.

• All other duties as assigned.

The Candidate

• Bachelor’s degree with 4 years of professional experience in the pharmaceutical industry, preferably with 2 years in a Quality role or;

• Associate degree with 5 years of professional experience in the pharmaceutical industry, preferably with 3 years in a Quality role.

• A combination of education and experience may be considered equivalent.

• 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