- University of Pennsylvania (Philadelphia, PA)
- …final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log. ... Program meetings, and working groups that will maximize the efficiency and quality of research performed; may be responsible for orientation/mentorship of new staff… more
- University of Pennsylvania (Philadelphia, PA)
- …and address queries. Show vigilance in participant safety, protocol compliance and data quality . Adhere to all University of Pennsylvania, FDA and GCP ... guidelines. Clinical Research Coordinator B is expected to perform the duties above with the additional expectations of effectively and independently managing multiple trials while also assisting other coordinators as needed. The CRC B will demonstrate… more
- Sumitomo Pharma (Harrisburg, PA)
- …specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... document alleged deficiencies related to the product, labeling, packaging, quality , durability, reliability, safety, effectiveness, or performance of CMS products… more
- Takeda Pharmaceuticals (Exton, PA)
- …travel required. **REQUIREMENTS:** Bachelor's degree in business management, quality assurance engineering management, computer science, or related field, ... different computer systems; knowledge and understanding of global regulations ( FDA 21CFR Part 11(210/211), 21CFR820, ISO-15489,ANNEX 11, etc.) related to… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of… more
- Teleflex (Wyomissing, PA)
- …medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in ... and ASTM and ISO guidelines for product/process qualification, validation, FDA submissions and legal requests. **Principal Responsibilities** **_Test Execution_** 1.… more
- Norstella (Harrisburg, PA)
- …data and align insights with client needs. + Monitor and troubleshoot data quality issues, ensuring the integrity and reliability of insights provided to clients ... while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions and helping… more
- Fortrex (Souderton, PA)
- …safe and sanitary environment, apply now to contribute to our mission of delivering top- quality products. **WHO WE ARE:** + Leader in food safety solutions for both ... 450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente… more
- University of Pennsylvania (Philadelphia, PA)
- …trials. Participate in the conduct of audits by study sponsors, CROs, the FDA , the Eastern Oncology Group, the University of Pennsylvania's CTSRMC, and other groups. ... working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOPs. Act as a mentor to newly… more