- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager , Quality ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to ... and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... review and drug product release practices.Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing… more
- Merck & Co. (Durham, NC)
- …the pharmaceutical manufacturing industry, specifically in pharmaceutical operations, technical operations, validation and/or process Quality Assurance . - ... required. Direct support of regulatory inspections and audits. Direct support of validation activities and all other associated Quality functions. Other duties… more
- Aequor (Louisville, KY)
- …What stands out on resumes - Experience working with a quality assurance organization, facilities engineering, a warehouse/factory environment, experience ... Minimum Education - Bachelor's with 4 years of experience C&Q Project Manager ?Responsible for managing the Commissioning and Qualification (C&Q) strategy or main… more
- BioAgilytix (Durham, NC)
- …budget.Workstream Coordination: Manage all internal BioAgilytix teams (lab operations, IT, quality assurance ) and external resources to ensure efficient project ... The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation,...Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead continuous improvement… more
- Aequor (Thousand Oaks, CA)
- …cross-functional program team. Works with the system, subsystem/platform, supply chain, service, QA , RA, Research project leaders to deliver quality products on ... to ensure projects deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such as; needle protection… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and the following minimum amount of relevant experience to the role for each level: + Project Manager QA Validation : 10+ years + Sr Project Manager QA ... We are looking to fill a Project Manager Validation (Fill Finish Oversight) position...our growing team. This position is responsible for providing quality oversight of validation and qualification of… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Validation Fill Finish team is hiring a Manager ! As the Manager , QA Validation you will validate/qualify equipment, systems, and processes related ... to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company… more
