Principal Quality Associate, Supplier Audits

Principal Quality Associate, Supplier Audits

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 Principal Quality Associate, Supplier Audits requires the ability to perform and facilitate system-based audits and risk assessments for Supplies Audits and Internal Quality Systems. The Principal Quality Associate, Supplier Audits will support non-commercial and commercial audits as well as the Inspection Readiness Program.

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

• Conduct external supplier audits (Desktop, Virtual or On-Site) per schedule, communicate findings and ensure CAPA plan is appropriate to address the findings.

• Ensure the Supplier Audit Team members are properly qualified and assign their roles and responsibilities; train staff to conduct or assist with audits and risk assessments.

• Participate in Regulatory Inspections and assist Inspection Readiness Team with inspection preparation, including walkthroughs and gathering of documentation, per inspection agenda as required.

• Assist with the generation of the Internal Audit Schedule, preparation and execution of Internal Quality Audits of Catalent systems / subsystems.

• Participate in process improvement projects and investigations, as required.

• Ensure all work is performed and documented according to approved standard operating procedures (SOPs), in general compliance with cGMPs, and in a timely manner consistent with agreed upon schedules.

• All other duties as assigned.

The Candidate

• Bachelor’s degree in a technical field with at least 6 years of professional experience in the pharmaceutical industry, 3 of which must have been in a Quality Auditing function or;

• Associate degree in a technical field with at least 7 years of professional experience in the pharmaceutical industry, 4 of which must have been in a Quality Auditing function or;

• In lieu of a technical field degree, at least 8 years of years of professional experience in the pharmaceutical industry, 5 of which must have been in a Quality Auditing function and completion of formal auditing training may be substituted.

• At least 5 years of experience in a direct Quality role required.

• Demonstrated knowledge of regulations and guidelines associated with cGMPs for pharmaceutical industry.

• Knowledge of manufacturing and/or laboratory processes required.

• ASQ CQA or equivalent certification preferred.

• Some exposure to hazardous chemicals and other active chemical ingredients.

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

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 p