- 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
- Terumo Medical Corporation (Allentown, PA)
- Territory Manager A, Allentown Date: Aug 26, 2025 Req ID: 4734 Location: Allentown, PA, US Company: Terumo Medical Corporation Department: TIS Sales - Tri-State ... the territory. Communicate market intelligence/competitor activity promptly to Region Manager . Develop and maintain good customer relationships, through personal… more
- Terumo Medical Corporation (Scranton, PA)
- Territory Manager -TIS, Allentown Date: Aug 21, 2025 Req ID: 4117 Location: Scranton, PA, US Company: Terumo Medical Corporation Department: TIS Sales - Tri State ... the territory. Communicate market intelligence/competitor activity promptly to Region Manager . + Develop and maintain good customer relationships, through personal… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Harrisburg, PA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… 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 ... requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- University of Pennsylvania (Philadelphia, PA)
- …studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. ... policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research...and/or CROs. + Show vigilance in patient safety, protocol compliance , and data quality. + Adhere to all University… 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, ... formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories. +...through effective reporting and communication. + Assist the QA Manager by ensuring WSS team members are trained in… more