- Formation Bio (New York, NY)
- …and approval of batch records, release testing, and other quality -related documentation . Foster a culture of continuous improvement and development within ... strategies that identify and address potential quality risks. Managing quality -related activities related to manufacturing, clinical trials, and nonclinical… more
- Jobleads-US (New York, NY)
- …This position will ensure regulatory compliance and continuous performance improvement . Responsibilities Ensure regulatory compliance within the Quality ... Quality Management RN Brooklyn, NY Monday - Friday...documentation , visit frequency, and billing compliance. Experience conducting clinical record reviews for accuracy, completeness, and regulatory compliance.… more
- Merck & Co. (Rahway, NJ)
- …key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to ... program cost estimates requested by Product Development Teams. Responsible for authoring clinical supply documentation in support of labeling and packaging… more
- Merck & Co. (Rahway, NJ)
- …#VETJOBS Required Skills: Adaptability, Adaptability, Change Control Processes, Change Management, Clinical Development, Clinical Documentation , Clinical ... supplies. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply...and Clinical Finished Goods). Responsible for authoring clinical supply documentation in support of labeling… more
- Merck & Co. (Rahway, NJ)
- …engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of ... enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of training programs to ensure relevance, accuracy, and regulatory compliance Implement quality improvement initiatives based on feedback and training analytics ... operations, medical affairs, and regulatory affairs Maintain training assignments on clinical research documentation , regulatory requirements, Good Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of GxP documentation to verify compliance and identify areas for improvement or corrective actions Collaborate with cross-functional teams to ensure that GxP ... performance against established metrics Prepare and present regular reports on documentation compliance, audit results, and improvement initiatives to senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Key Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement .Deputize for the Sr. Director, Medical Affairs QA as needed. ... stakeholders are educated on common deviations.Ensure proper planning and execution of and quality improvement initiatives to reduce issues to build a stronger … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tasks at all times Provides strategic input and contributes to process / quality improvement initiatives Guides the successful completion of major programs or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , technical ... site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.Review of all documentation , in accordance with Good … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Compliance, Global Safety, and centralized teams (eg, Training and Documentation , Quality , Supplier and Contract Management and Digital Enablement). ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the development of manufacturing processes including appropriate documentation .Drive continuous improvement of manufacturing operations leveraging ... scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supporting various company initiatives and functions such as Marketing, IT, Clinical , Research, Operations, Patient Support Programs, and Digital Health Lead cross ... practices and ethical standards in legal counsel Lead Process Optimization and Improvement Lead and optimize Corporate Law and Legal contracting support processes,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP Commercial Facility.Experience with Asset Change Control, Process/System Improvement , Asset Lifecycle activities/ documentation .Excellent knowledge of project ... for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering support for building automation and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be ... inclusive of life cycle management, issues, deviations, corrections, remediation and improvement efforts of automation and controls systems for facility, equipment,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …various materials including (but not limited to) critical supplies, clinical materials, components and consumables.Develop, maintain and actively manage ... accurate open purchase order listing, un-invoiced receipt amounts, supplier documentation and statements.Monitor product life cycles and alert appropriate team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of various materials including (but not limited to) critical supplies, clinical materials, components and consumables.Participate in regular Site Supply Chain / ... and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide timely… more
- National Health Care Associates (Melville, NY)
- …dignity, and well-being at the center of everything you do. + Review clinical documentation and care processes to ensure that residents receive appropriate, ... team! **-** **What You'll Do:** As theRisk Manager & Quality Assurance Coordinator(RN),you'll play a vital leadership role in...technology use. + Monitor for patterns and trends in clinical outcomes and safety events, and turn data into… more
