- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... quality systems records.Support CAPA site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good… 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- Terumo Medical Corporation (Somerset, NJ)
- …world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Terumo Medical Corporation (Somerset, NJ)
- …world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… 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)
- …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
- 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
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- … Operations, and Information Systems to optimize medication-use workflows. + Support clinical safety, compliance, and quality initiatives aligned with USP, Joint ... administration, sterile compounding, and inventory management. + Develop and maintain documentation , training materials, and user resources for clinical staff.… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Documentation Quality Improvement Specialist II is responsible for improving the overall quality and completeness of ... or CCDS **Responsibilities** 1. Facilitates improvement in the overall quality , completeness and accuracy of medical record documentation through concurrent… more
- Elevance Health (Woodbridge, NJ)
- …a minimum of 10 years of experience in claims auditing, quality assurance, or clinical documentation improvement , and a minimum of 5 years of experience ... with third party DRG Coding and/or Clinical Validation Audits or hospital clinical documentation improvement experience preferred. + Broad knowledge of … more
- Deloitte (Morristown, NJ)
- …+ Operational Improvement : For business process that include significant clinical documentation and regulatory requirements, you will improve efficiency and ... nurse, physician, physician assistant, case manager, clinical documentation specialist, utilization review, informatics RN, Quality ,...IPPS payment system is a plus' + Experience in quality measurement, quality improvement , and… more
