Quality Assurance Specialist, Commercial Manufacturing

Quality Assurance Specialist, Commercial Manufacturing

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.

Second Shift: Monday – Thursday, 4 PM – 2:30 AM         

The Quality Assurance Specialist 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. The Quality Assurance Specialist will perform batch record review and on the floor Quality Assurance commercial manufacturing support.

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

• Review quality documentation including but not limited to review and release of batch records and/or product, release of equipment, room set up, room clearance, initial documentation of unplanned events as appropriate.

• 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.

• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standard. Perform gemba walks of manufacturing and packaging areas. Work to create an environment of open communication, participation, and information-sharing within and between teams within quality assurance and throughout the facility.

• 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 manufacturing with appropriate quality oversight. Provide real-time support activities for manufacturing and packaging.

• Escalate unplanned events and issues, providing immediate notification to QA Management, supporting and providing guidance to manufacturing staff. Demonstrate knowledge of root cause analysis techniques to support manufacturing investigation teams.

• 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. Become proficient in ERP System, Document Management System and TrackWise.

• Other duties as assigned.

The Candidate

• Bachelor’s degree with 4+ years of professional experience in the pharmaceutical industry and 2 years in a direct QA role required OR

• Associate degree with 5+ years of professional experience in the pharmaceutical industry and 3 years in a direct QA role required.

• Must have experience with batch record review and on the floor Quality Assurance commercial manufacturing support.

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

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds.

Why You Should Join Catalent

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment.

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement