- Sanofi Group (Swiftwater, PA)
- …(including dedicated clean utilities) of the building that the Automation Site Support Manager has been assigned to. + The position will be the Automation Site ... Familiar with local and federal code requirements such as FDA CFR, NFPA/ NEC, OSHA, DEP, EPA and industry...on IoT setup to ensure stable integration I: Inform project requirements and task progress for resource planning A:… more
- Fujifilm (Harrisburg, PA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- University of Pennsylvania (Philadelphia, PA)
- …research patient safety and data integrity. This position will report administratively to the project manager in the Department of Medicine and will report, on a ... to be in line with corrective action plans. Support site involvement in FDA auditing and submission of NDAs. Assist with writing, editing, and submitting study… more
- University of Pennsylvania (Philadelphia, PA)
- …is expected to perform the duties above with more limited supervision from the project manager . In addition, will develop complex documents such as protocols and ... in patient safety, protocol compliance and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines. The Clinical Research Coordinator C… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... role is a technical resource supporting business process and systems. Working with project stakeholders in all business areas, the Quality Technician will help with… more
- Fujifilm (Harrisburg, PA)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …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 ... each performed work order. Takes direction from the Facilities Manager , Maintenance Technician II and the Maintenance Coordinator **This...position desired + Good knowledge of the application of FDA cGMP's is a must + Individual may be… more
- University of Pennsylvania (Philadelphia, PA)
- …is expected to perform the duties above with more limited supervision from the project manager . In addition, will develop complex documents such as protocols and ... consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met.… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... and other projects and assist Research Team Managers in overseeing execution of project timelines as well as completion of study related activities including but not… more