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QA 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 Inspector** . The Quality department is responsible for creating/maintaining the Quality Management System for the Clinical Services facility at Philadelphia. This Quality Management System includes Documentation Control, Investigation and CAPA Management, Training, Internal/External Audits, Customer Correspondence, Validation, and also includes Quality Assurance of the Operation such as process monitoring and control, quality auditing including batch record review and final release.

This is an onsite, full-time, hourly role position: Monday-Friday: 3:45pm-12:15am - 2nd shift (weekends as needed)

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 reconciles materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.

+ Inspects and releases all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook.

+ Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.

+ Reviews and understands both the Production Protocol and QA Protocol prior to starting the Clinical Packaging process.

+ Performs and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA Protocol and SOPs requirements as well as ensuring that the Production Protocol and GMP standards are being followed.

+ Reviews the batch record and any associated paperwork for any documentation errors made during the clinical packing operation and again when the job is completed prior to submitting the batch record to document control.

+ Reviews EMS system printouts for out of specification temperatures, humidity and pressures.

+ Ensures that all Inventory Management System printed labels are correct against the information provided in the associated protocol.

+ Performs walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed.

The Candidate:

+ Bachelor’s degree preferred OR a minimum of 3 years of Production/QA experience.

+ Proven track record of monitoring/auditing for Quality and of identifying potential efficiencies in a Production environment.

+ Good Communication Skills, both written and verbal.

+ Strong interpersonal skills and is comfortable working in a team environment.

+ Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus (JD Edwards 9.1 preferred)

+ Basic knowledge of Lean Six Sigma methodologies an advantage

+ Good knowledge of the application of FDA cGMP’s.

+ Exercises sound judgment and are analytical in thought.

+ Comfortable working in a dynamic environment with many conflicting priorities?

+ Ability to quickly learn and implement QA Auditing techniques.

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 innovative

+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

+ 152 hours of PTO + 8 paid holidays

+ Several Employee Resource Groups focusing on D&I

+ Dynamic, fast-paced work environment

+ Community engagement and green initiatives

+ Generous 401K match

+ Medical, dental and vision benefits

+ 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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .