- Cook Medical (Pittsburgh, PA)
- …methodology associated with manufacturing a cell therapy product in an FDA -regulated environment.* Experience in Quality Assurance and/or Compliance functions ... helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical...CVs and medical licenses, record of IRB certification and compliance ). + Resolve regulatory related queries with… more
- West Pharmaceutical Services (Exton, PA)
- …**Job Summary** The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, ... and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... various sponsors. This position will report directly to the Airways Program Manager and work directly with Physician Investigators ("PI") on clinical research… more
- University of Pennsylvania (Philadelphia, PA)
- …and renewals in accordance with FDA and IRB guidelines + Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and ... execution of research protocols. Attention to patient safety, data integrity, and regulatory compliance is essential. This position requires adherence to… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... Management System (QMS). The position will work together with Regulatory Affairs, Engineering, Operations, and Purchasing/Procurement to ensure product quality… more
- Kedplasma (Pittston, PA)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... Affairs, Research & Development, Legal, and Health Care Compliance . **Job Duties** + Candidate with Bilingual skills -...+ Various standards (GCP, ISO 13485, ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …senior leader will drive cross-functional initiatives to enhance product safety, regulatory compliance , and customer experience through advanced data analytics, ... reporting. + Stay abreast of emerging digital technologies and regulatory trends to ensure sustained compliance . +...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize… more