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 Assurance Supervisor, Production. The Quality Inspector is responsible for process monitoring and auditing of packaging operations, the duties including real-time batch documentation review, monitoring of adherence to cGMP, training on cGMP where necessary, and supporting actions (if required) for resolution of deviations and investigations. The scope of work will cover packaging room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will identify opportunities to improve the ‘right-first-time’ performance of the operation and will manage those opportunities to implementation and improvement, in partnership with Production personnel.

This is a full-time role position: Monday-Friday: 7:45am-4:15pm, 1st shift. 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 packaging operations. This may require the simultaneous auditing and/or monitoring of one or more operations
• Verifies and/or reconciles materials to and from production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies
• Inspects and releases all packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents activities accordingly in the associated logbook(s). Reviews production logbooks for GMP compliance
• Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up records both prior to the start and during the packaging process (if necessary) for any jobs using packaging machinery. Reviews and understands both the Production Protocol and QA Protocol prior to starting the packaging process. Performs and documents hourly QA Inspections on assigned packaging rooms as per both the QA Protocol and SOP requirements
• Ensures that the Production (Packaging) Protocol and GMP standards are being followed during the packaging process. Reviews the batch record and any associated paperwork for any documentation errors made during the packaging operation and again when the job is completed prior to submitting the batch record for final review and release. Reviews environmental monitoring system printouts for out of specification temperatures, humidity, and/or pressures
• Prints and reviews Material Usage Reports for packaging job(s) and/or operation(s) to ensure that th