- Catalent, Inc. (Philadelphia, PA)
- …record review and release. The position requires communication between the operations /production, project management, shipping and quality assurance groups to ... consumer, and Catalent employee. The Role: Independently manage assigned projects or support the Project Management (PM)...production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review… more
- BeiGene, Inc. (Pennington, NJ)
- …on cost of goods reduction. Scale-up through technology/process transfer to clinical and commercial manufacturing. Ensure accurate and complete documentation of any ... scientific experimental plans, data and reports. Uphold all cGMP standards for process qualification, deviation investigations and all related documentation. Utilize… more
- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title cGMP Operations and Clinical Projects Associate Job Profile Title Research Coordinator ... (GMP) guidance and Good Laboratory Practice (GLP) compliance. The cGMP Operations and Clinical Projects Associate will serve as a liaison across multiple… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …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 ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Kelly Services (Titusville, NJ)
- …quality oversight for pharmaceutical (or equivalent) production, including manufacturing operations , cGMP compliance, and non-conformance investigation. + ... integration of external manufacturing facilities. Support a variety of projects both internally and with external manufacturers. **Qualifications:** **Education:** +… more
- Catalent Pharma Solutions (Malvern, PA)
- …employee. **The Role** + Carry out all duties in line with the QA / cGMP / Safety standards at CMTI. Carry out the analytical testing activities of pharmaceutical ... compendial testing, etc. Support Management by communicating directly with clients regarding new projects , on-going projects , etc. + Able to evaluate data and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …our ability to plan and execute the production of commercial and late-stage clinical products efficiently, timely, and with high quality. Scope of the role covers ... of the role will be CI of Commercial or clinical products. The role will provide coaching, direction and...year on year and developing a healthy pipeline of project for future years. The role will have no… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …record review and release. The position requires communication between the operations /production, project management, shipping and quality assurance groups to ... and Catalent employee.** **The Role:** + Independently manage assigned projects or support the Project Management (PM)...production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol Includes review… more
- BeOne Medicines (Pennington, NJ)
- …shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. ... + Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment.… more
- ThermoFisher Scientific (Collegeville, PA)
- …+ Provides on-site management and direction to laboratory staff and resources for project activities and needs, oversee daily operations to monitor quality and ... experimental data/electronic lab notebook experiments for formulation/process development samples and clinical trial supplies (eg cGMP compliant stability and… more
- BeOne Medicines (Pennington, NJ)
- …on cost of goods reduction. + Scale-up through technology/process transfer to clinical and commercial manufacturing. + Ensure accurate and complete documentation of ... any scientific experimental plans, data and reports. + Uphold all cGMP standards for process qualification, deviation investigations and all related documentation. +… more
- Kelly Services (Malvern, PA)
- **QA Associate** Kelly(R) Science & Clinical is seeking **2** **nd** **Shift** **QA Associate** for **a contract to hire** position with a growing chemical ... driven studies for AET testing. + Provides written and verbal updates on projects and activities as required. + Troubleshoots equipment and methods. + Analyzes and… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …+ Leads communication between functional areas of the organization (ie. BD, Project Management, Operations , Quality, Finance, etc) to ensure on-time delivery ... Client Services, identifies and independently drives delivery of strategic process improvement projects on behalf of the global team and/or the business **.** **The… more
- J&J Family of Companies (Spring House, PA)
- …Quality Assurance specialists responsible for the quality oversight of supply chain operations supporting production of commercial and clinical drug substance in ... providing input on the site goals and objectives, prioritizing projects , and coordinating resource allocation to meet base business...audits. + Provide leadership and insight as on global project teams. + Other duties may be assigned as… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... 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… more
- J&J Family of Companies (Spring House, PA)
- …providing quality oversight for daily activities related to commercial supply chain operations supporting production of commercial and clinical drug substance in ... and approve investigations and CAPAs, change controls, protocols, reports, area releases, project planning and site procedures. + Provide quality input on a variety… more
