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.  Quality Assurance Inspector position 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. 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 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 ProjectManagement 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 complianceSupports 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 processPerforms 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 processReviews 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 releaseReviews 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 the drug product quantities documented in the batch record match those that are entered in the Inventory Management SystemEnsuring that all Inventory Management System printed labels are correct against the information provided in the associated protocol.  Updates the daily/shift QA turnover log with all pertinent information regarding activities during the assigned rooms and shifts and forwards relevant notes to all pertinent employeesPerforms walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed. Partners with other departments in resolving unplanned deviations, investigations and in troubleshooting. Performs additional sampling/testing protocols on clinical trial materials as requested by the customerPerforms equipment parts inspection, approval and storage as required per SOPs. Inspects and verifies that all clean storage rooms meet approval criteria as per SOPs. Participates in customer audits when required. Performs other duties or tasks as requested or required by QA ManagementAll other duties as assigned; 

The Candidate 

Required a High School Diploma. Bachelors Degree highly preferredA minimum of three years of Production/QA experience is requiredWorking knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required. Inventory Management system experience is a plusProven track record of monitoring/auditing for quality assurance and/or identifying potential efficiencies in a production environment preferredKnowledge reading engineering drawings/material specifications, a plusKnowledge of the application of FDA cGMP’s highly desiredIndividual may be required to sit, stand, walk regularly and occasionally lift up to 50 poundsOccasional requirement to work in cold environment to fill orders (walk-in refrigerator/freezer)

Why you should join Catalent:

Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiatives Generous 401K match Medical, dental and vision benefits effective day one of employment Tuition Reimbursement - Let us help you finish your degree or start a new degree!WellHub- program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.