Quality Assurance Supervisor Commercial

Quality Assurance Supervisor

Position Summary:

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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging.  Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.  Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Supervisor. The Quality Assurance Supervisor reports to the Quality Assurance Manager and supervises the Quality Production Inspectors over a single shift for production related activities that require quality input and oversight. Ensures regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for leading in production area auditing functions, performing/reviewing product quality complaint investigations and process deviations. Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Quality Assurance Supervisor will be responsible for making quality decisions on behalf of the department when the Quality Assurance Manager is unavailable.

This is a full-time, salaried role on-site. This is on 1st shift.

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 Role:

• Supervise daily activities of Quality Inspectors, ensuring timely turnaround and appropriate resource assignment to complete / meet the requirements of the daily business activities
• Responsible for understanding all duties performed by the Quality Inspectors
• Assign/coordinate daily activities of the Quality Inspectors including assignment of specific projects
• Ensures that Quality Inspectors complete assigned tasks in accordance with SOPs
• Lead/coach/mentor Quality Inspectors to assist the employees in reaching development goals
• Conduct audits of all respective Production areas to assure compliance with cGMPs, corporate and network policies and standards, and local standard operating procedures
• All other duties as assigned

The Candidate:

• Requires a Bachelor’s Degree; Strongly preferred degree in Regulatory Affairs, Biotechnology, Engineering, Manufacturing, Operations, Supply Chain or related discipline
• Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment
• Previous supervisory experience of at least five years preferred
• Experience in a regulated field – pharma, food, automotive, etc. preferred
• Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred
• Required Leadership skills include excellent interpersonal and communication skills with cross-functional teams, the strong ability to lead, me