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Quality Assurance Supervisor - Philadelphia Pennsylvania
Company: Disability Solutions Location: Philadelphia, Pennsylvania
Posted On: 05/18/2024
QA SupervisorPosition SummaryCatalent Pharma Solutions in Philadelphia, PA is hiring a QA Supervisor.-- The QA Supervisor will provide Quality Assurance support for the Quality Inspectors on the production floor, incoming material quality, and/or distribution quality, including quality oversight for material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA requirements. They will provide customer satisfaction and operational efficiency. This is a full-time position: Monday - Friday, days.Catalent is a global, high-growth, public 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 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 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 all QA activities related to incoming, distribution and destruction and process auditing
- Assist in ensuring the quality and identity of pharmaceutical products during all aspects of the incoming, distribution, or packaging processes
- Act as the Quality partner to support the Supply Chain and Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution Practices"
- Act as lead investigator for all compliance issues regarding incoming, distribution, returns, destruction, or packaging/production
- Develop process excellence and efficiencies prior to the beginning of a project; Track and report metrics and identify trends and predictive models
- Review and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory, and customer requirements
- Support Corporate and local Quality policies and initiatives. Support compliance for USDA, HHS, state, and foreign regulatory bodies
- Anticipates internal and or external business challenges and/or regulatory Issues; recommends process, product or service Improvements
- Perform all related duties and/or other functions as requiredThe Candidate:
- High school diploma or general education diploma is required
- College degree is preferred
- Minimum of 5 years in a Pharmaceutical or Medical industry is required
- Previous Supervisory experience 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 cGMP's
- Ability to quickly learn and implement QA Auditing techniques
- Knowledge reading engineering drawing/material specification, a plus
- Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 poundsWhy you should join Catalent:
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