- Aequor (Thousand Oaks, CA)
- …(SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements. ... Preferred experience managing in Track Wise or Veeva Systems Basic project management skills required.The Specialist Manufacturing is expected to own and… more
- Novo Nordisk Inc. (Durham, NC)
- …DV/CAPA, Change Control, Audits, Supplier Management , Project Management , Validation, etc.) required Experience with regulatory requirements computer ... will be Audits and Inspections. The Sr. QA Area Specialist will host internal audits, serves as facilitator during...of batch reports & release of incoming materials, deviations, change controls, review & approval of SOPs, QA presence… more
- Merck & Co. (Rahway, NJ)
- …devices or combination products Experience in design controls, ISO 13485, deviation management , change control, risk management /ISO 14971-2019 and the ... in biotech organizations Five plus years in design control, risk analysis and change control management for medical device or combination products- Demonstrated… more
- Novo Nordisk Inc. (Durham, NC)
- …DV/CAPA, Change Control, Audits, Supplier Management , Project Management , Validation, etc.) required Experience with regulatory requirements computer ... of batch reports & release of incoming materials, deviations, change controls, review & approval of SOPs, QA presence...support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards ... Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring the highest standards of scientific integrity, patient safety, regulatory compliance, and collaboration across therapeutic areas. Ultimately, this position ... interact with senior leaders/leadership, on occasion. Essential Functions Stakeholder Management Ensure effective and impactful cross-functional collaboration with consistent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with senior leaders/leadership, on occasion. Essential Functions Stakeholder Management : Ensure effective and impactful cross-functional collaboration with ... across stakeholders (Global Research, Global Development, Market Access, Marketing, Regulatory Affairs, Safety, International Operations, Regions & Affiliates, NN… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or ... to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the establishment and … more
- Comerica (Farmington Hills, MI)
- Regulatory Change Management Specialist The Regulatory Change Management Specialist reports to the Manager of Regulatory Change ... Management and is responsible for facilitating all aspects of the Regulatory Change Management (RCM) process and contributing to administrative updates to… more
- Comerica (Farmington Hills, MI)
- Regulatory Change Management Sr Specialist The Regulatory Change Management Sr Specialist reports to the Manager of Regulatory ... Management and is responsible for facilitating all aspects of the Regulatory Change Management (RCM) process. This includes ensuring that new … more
