- Parexel (Harrisburg, PA)
- …Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, ... + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Ensure compliance with regulatory standards relevant to medical devices (eg, FDA , EMA, PMDA), quality systems/SOPs, data integrity and audit readiness. + Lead ... disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It is the policy… more
- BioFire Diagnostics, LLC. (Philadelphia, PA)
- …GiCS (global industry customer service) representatives, manufacturing site quality manager , program directors and Industrial Applications Quality Managers. + Be ... participation in the management of regulatory audits (ie ISO 9001,ISO 13485, FDA , etc.). + Manage and meet competing deadlines, requiring careful prioritization and… more
- Penn Medicine (Philadelphia, PA)
- …protocol + Communicates with patients regarding patient flow and wait times - keeps manager aware of potential issues as they arise. * Issues referrals and obtains ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Change Management: + Flexible and readily… 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 ... the status of ongoing patients; discuss updates/issues with the Research Team's Program Manager and prepare updates/meeting minutes. Work as a part of the research… more
- Norstella (Harrisburg, PA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... with early client exposure, increasing ownership, and a clearly defined path to Manager for high performers within 2-3 years. SeniorAnalysts will work on projects… more
- GE HealthCare (State College, PA)
- …**Location: State College, PA** **Reports To: Facilities Supervisor / Operations Manager ** **Position Summary:** We are seeking a reliable and detail-oriented ... + **Compliance & Safety:** + Follow strict cleaning procedures aligned with ISO, FDA , and GMP standards. + Use appropriate PPE and cleaning ,agents specified in… more
- Penn Medicine (Philadelphia, PA)
- …to the individual, they will work with the Division's Quality Assurance manager in functioning as liaison to accrediting/regulatory agencies in preparation for ... CAP (College of American Pathologists), CLSI (Clinical Laboratory Standards Institute), FDA , FACT, TJC (The Joint Commission), OSHA (Occupational Safety and Health… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... CRM software (Salesforce). Essential Functions + Work with Salesforce project manager , implementation consultants, business SMEs and technical teams in understanding… 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