Quality Assurance Inspector

Quality Assurance Inspector

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 is hiring a Quality Assurance Inspector. The Quality Assurance Inspector reports to the Quality Supervisor. The Quality Inspector is responsible for performing inspection and release of all components, clinical trial and commercial labels, drug products, distribution materials and paperwork as well as materials slated for destruction and associated paperwork, while ensuring SOPs and cGMP are being followed. The Quality Inspector will identify opportunities to improve the processes, raise these to Quality Management and assist in the implementation and improvement of these processes, in partnership with Supply Chain personnel, Project Management, and Operations.

This is a full-time role position: Monday-Friday: 8:00am-4:30pm. Hourly, Onsite

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  

• Responsible for ensuring that Standard Operating Procedures are consistently followed, and that cGMP’s are observed, in the course of incoming inspection, distribution, label control, destruction and returns. This may require simultaneous auditing and/or monitoring of one or more processes.  This role can support both Commercial and Clinical Operations

• Verifies and inspects incoming materials and works accordingly with Quality and Project Management to handle any possible discrepancies

• Perform inspection and release of all clinical and commercial drug products and components received from customer or vendor as per customer specifications protocols and/or Catalent SOPs, includes review of all inventory labels applied to the containers and paperwork generated from JDE with receipt paperwork

• Perform inspection and release of all shipping and distribution materials to clinical sites or clients by reviewing all associated paperwork and picked material, including verification of each individual randomized container and compliance with customer specific distribution protocols

• Perform inspection and release of materials slated for destruction, by reviewing the associated paperwork and picked materials. Inspect and release of clinical open, randomized, single panel booklet and multi language labels produced by external vendors and Clinical Supply Services by comparison to approved label proof or label copy request

• Reviews BMS system printouts and chart recorder printouts for out of specification temperatures, humidity and pressures. Inspect retain samples, as required. Maintains & provides departmental metrics. Assists in walk through audits of the Supply Chain facility, Label control room, Refrigera