Quality Assurance Inspector

**Quality Assurance Inspector****Position Summary:**Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.This 206,878 square-foot facility, located in the Philadelphia area is Catalents 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 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 implement and improve, in partnership with Production personnel.**This is a full-time, hourly role. This is onsite. This position is a 1st shift role. The hours are Monday Friday, 7:45am-4:15pm.****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 cGMPs 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+ 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 employees+ Performs walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMPs are being followed+ All other duties as assigned**The Candidate:**+ Bachelor degree is required+ At least three years of experience in Production or Quality Assurance is preferred+ A demonstrated history of effectively monitoring or auditing for quality assurance, as well as recognizing possible efficiencies within a production setting, is preferred+ Good computer skills; Knowledge of MS Office and Inventory Management system are a plus+ Basic knowledge of Lean Six Sigma methodologies an advantage+ Good knowledge of the application of FDA cGMPs+ Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds**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+ Company match on donations to organizations+ 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 (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 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .