- Integra LifeSciences (Plainsboro, NJ)
- …updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development ... updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development… more
- Sanofi Group (Morristown, NJ)
- …guidance on Chemistry, Manufacturing , and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our department bridges ... with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence… more
- Integra LifeSciences (Princeton, NJ)
- …requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations. This role will be responsible ... attaining the company's improvement objectives and growth strategies across Integra manufacturing facilities and a diverse portfolio of leading medical devices. This… more
- Merck (Rahway, NJ)
- …Manufacturing , GMP Compliance, Innovation, Life Science, Management Process , Manufacturing Scale-Up, Process Improvements, Product Commercialization, ... CMC development and commercialization strategy which yields the target commercial product . The specific role will be responsible for advancing the company's… more
- Merck (Rahway, NJ)
- …Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management Process , Manufacturing ... support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally. The Packaging Technical Operations organization aims… more
- Integra LifeSciences (Plainsboro, NJ)
- …manner. + Support NCs and CAPA investigations as required. + Assist with product flow between departments. + Interface with Manufacturing department in order ... Inspector** serves as a Lead Associate, Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center (CMC). The lead associate is… more
- embecta (Parsippany, NJ)
- …on embecta growth initiative projects. The role will support full product life cycle management activities which include identification and interpretation of ... manner. + Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (US) for changes that do not… more
- Integra LifeSciences (Plainsboro, NJ)
- …quality assurance inspections on purchased components, manufactured sub-assemblies and final product . The Quality Inspector will perform all duties in accordance to ... overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be… more
- Integra LifeSciences (Plainsboro, NJ)
- …and batch mixing in a new state of the art automated manufacturing environment. Responsibilities include batch execution, in- process quality verifications, ... (SOP's), and Health and Safety requirements. + Performs and supports daily manufacturing operations inclusive of batch execution, product inspections, setup,… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …**Skills & attributes:** + Strong understanding of pharmaceuticals, with a combination product or medical device manufacturing , packaging and testing ... who will conduct assessment on company sites, internal GMP (Good Manufacturing Practices) departments, external partners, and quality systems for ensuring compliance… more
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