- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality ... NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary Physical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary ... at all levels within the organization and function within the role of Quality Business Partner where requested by management Develops comprehensive, relevant… more
- Repligen (Waltham, MA)
- … quality assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management , regulatory.… more
- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and ... and release including deviation support, root cause analysis, customer complaint management , hosting customer/regulatory audits and Certificate of Quality … more
- Eisai, Inc (Nutley, NJ)
- …(CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for… more
- Merck & Co. (Rahway, NJ)
- …action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & ... Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System, Quality Management , Quality Management … more
- Merck & Co. (Rahway, NJ)
- …global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality ... process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Repligen (Hopkinton, IA)
- …position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for inspecting, auditing ... in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.Ability to communicate with multiple departments and associates.Shares… more
- Merck & Co. (Rahway, NJ)
- …(8) years combined experiences in commercial/business and manufacturing (operations, project management , or quality , technology, supply chain etc.) function in ... Focus, Operational Strategies, Outsourcing, Process Improvements, Production Scheduling, Project Management Planning, Quality Compliance, Regulatory Compliance {+… more
- Eisai, Inc (Raleigh, NC)
- …Records (MBRs)Assist with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation, and reporting ... hear from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… more
- Repligen (Hopkinton, IA)
- …Director.This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the ... years' experience in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office, including Word and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from the GSOP Committee)Proactively manage ... or related field required Experience:4 or More Years Experience in quality management in the pharmaceutical industry and quality (GxP) requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and monitors all RBQM activities and deliverables in terms of timeline and quality .- People Management Leadership: Accountable for the management , ... and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D.… more
- Merck & Co. (Durham, NC)
- …IT Operation, Problem Management , Process Automations, Production Optimization, Quality Management , Real-Time Programming, Software Development Life Cycle ... an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- Supports a spectrum of sophisticated automated… more
- Twist BioScience (South San Francisco, CA)
- …to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and ability to develop ... decisions and exercise sound judgment.Strong work ethic, commitment to the highest quality of workProficient with project management tools and applications (such… more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... that the operation is in compliance with all aspects of Repligen's IS09001 Quality Management Responsible for ensuring that work area is clean and safe Report… more
- Novo Nordisk Inc. (Durham, NC)
- …for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive analytics and ... the Lead and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective… more
- Merck & Co. (Durham, NC)
- …Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
