- Deloitte (Pittsburgh, PA)
- …capabilities to build, deploy, and operate integrated/verticalized sector solutions in software , data, AI, network, and hybrid cloud infrastructure. These solutions ... familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND,… more
- Fujifilm (Harrisburg, PA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …of financial and business concepts. + Experience working to regulatory standards: FDA , Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good ... pertaining to Pharmaceutical industry. Fully competent in the use of common computer software - Microsoft Windows, Microsoft Word, and Microsoft Excel. + Must be… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Fujifilm (Harrisburg, PA)
- …+ Provide on-going customer support for HCUS MRI products, including: + Software updates. + System upgrades. + Performance troubleshooting follow-up visits. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Control related to QA and warehouse operations + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Ensure US Allentown distribution warehouse is ... requirements for the pharmaceutical industry. + Strong proficiency with applicable computer software , SAP and MS applications Physical Demands and Abilities + The… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …of destruction of pharmaceuticals drug products. + Support regulatory inspections ( FDA , DEA, VAWD/NABP, NJDOH etc.) + Ensure US Allentown distribution warehouse ... requirements for the pharmaceutical industry. + Strong proficiency with applicable computer software , SAP and MS applications. Physical Demands and Abilities + The… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Globus Medical, Inc. (Audubon, PA)
- …collect data, establish facts, and draw valid conclusions + Knowledgeable with CAD software (eg Pro/E, CREO, and/or SolidWorks) and Microsoft Office suite + Ability ... respond and adapt to changing priorities + Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to,… more
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