- Penn Medicine (Philadelphia, PA)
- …students. **Regulatory Compliance** : + Works with the Division's Quality Assurance manager in functioning as liaison to accrediting / regulatory agencies in ... CAP (College of American Pathologists), CLSI (Clinical laboratory Standards Institute), FDA , FACT, TJC (The Joint Commission), OSHA (Occupational Safety and health… more
- Penn Medicine (Yardley, PA)
- …Summary: + The Certified Nursing Assistant (CNA) assists the practice manager and physicians in maintaining a patient/customer focus, supports the delivery ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes… more
- University of Pennsylvania (Philadelphia, PA)
- …(PI), study team and Sponsor/CRO. This position will report directly to the Program Manager and work directly with PIs and clinical research nurses (CRNs). The CRC ... final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log.… more
- University of Pennsylvania (Philadelphia, PA)
- …safety, protocol compliance and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines. The Clinical Research Coordinator C 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… more
- PCI Pharma Services (Philadelphia, PA)
- …new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to ... function of this position Performs other duties as assigned by Manager /Supervisor. **Qualifications:** The requirements listed below are representative of the… more
- UPMC (Altoona, PA)
- …productivity. + Maintain assigned vehicle in a clean and orderly condition; inform Manager of Pharmacy of mechanical problems. + Pick up sharps containers and ... compliance with State, local, and Federal laws and/or regulations (including FDA , DOT,OSHA,etc.) + Maintain confidentiality of patient information. + Document… more
- Fujifilm (Harrisburg, PA)
- …opinion leaders in the Endoscopy space. The role of the Business Development Manager is to understand and define our internal and external endoscopic customers' ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... + Facilitates MES (Camstar) / ERP (Epicor) validation activities in an IS0-13485/ FDA regulated environment. + Supports product and process change implementation by… more
- West Pharmaceutical Services (Exton, PA)
- …as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. + Create and maintain system lifecycle documents in accordance with West ... experience required **License and Certifications** + Information Technology\Certified Scrum Manager Upon Hire preferred **Travel Requirements** 10%: Up to 26… more
- PCI Pharma Services (Philadelphia, PA)
- …and installation to meet customer requirements. + Assure compliance to GMP's, SOP's, FDA , DEA and OSHA rules and regulations. + Interact with all customers and ... Update JDE with daily work hours + Performs other duties as assigned by Manager /Supervisor. + This position requires extra hours and/or weekend work. + Knowledge of… more