- Merck & Co. (Rahway, NJ)
- …learned.clinicaltrialjobsEligibleforERPRequired Skills: Accountability, Accountability, Adaptability, Clinical Data Management , Clinical Development, Clinical ... quality activities within the assigned therapeutic area.- This includes operational quality management and inspection management activities.The CQOM will… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Merck & Co. (Rahway, NJ)
- …ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling and ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… more
- Merck & Co. (Rahway, NJ)
- …acumen supporting pre- and post-implementation processes.Proficient in order processing, sales/customer data management , operational management and process ... and end customers.Develop strategic plans to develop or evolve processes/platforms ensuring data reliability/ quality , scalability and business rules to ensure a… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... to ensure compliance with industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment:… more
- Merck & Co. (Rahway, NJ)
- …Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... collaborate regularly with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Merck & Co. (Rahway, NJ)
- …Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation Management , Equipment ... and IT teams.Support establishment of GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
- Merck & Co. (Rahway, NJ)
- …excellence in support of the portfolio of work, including interrogation of the data / science through technical reviews and exploring alternative ways to view and ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Skill (Clark, NJ)
- …updates and loads using various tools, including SAP. * Proactively monitor, analyze, and resolve data quality issues in a timely and efficient manner. * ... , including incident routing and escalation. * Support various data quality projects as needed, contributing to...with the ability to quickly learn and master internal data management systems. **About Aquent Talent:** Aquent… more
- FreshRealm (Linden, NJ)
- …hour) + Document all audits in Quality Tool Suite + Notify Specialist and Quality Auditor of any issues + Attend monthly refresher trainings with Quality ... **General Job Description** FreshRealm looking for a Quality Control Technician Level 2 in our Fulfillment...norms, assumptions, and best practices Experiment and take calculated, data -driven risks + **OBJECTIVITY** : Utilize data … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operate PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with ... training modules and support decision-making for global/regional projects Evolve Project Management (PM) Processes: - Contribute to improving project management … more
- FreshRealm (Linden, NJ)
- …organoleptic, and packaging integrity testing + Maintain records and forms from Quality Management System software **QUALIFICATIONS FOR THE JOB** **Skills and ... hourly check, GMP audit, internal audit, FSQA tickets, Customer issues and CAPAs. + Investigate quality and...norms, assumptions, and best practices Experiment and take calculated, data -driven risks + **OBJECTIVITY** : Utilize data … more
- FreshRealm (Linden, NJ)
- …and liaise with other Departments / Plant Managers on addressing the resulting issues . + Effectively manage the labor resource and control this to within the ... given budgets/targets for the required output. + Deal with staff issues of discipline, grievance, and welfare within the guidelines laid out in the Company's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… more
- FreshRealm (Linden, NJ)
- …and liaise with other Departments / Plant Managers on addressing the resulting issues . + Effectively manage the labor resource and control this to within the ... given budgets/targets for the required output. + Deal with staff issues of discipline, grievance, and welfare within the guidelines laid out in the Company's… more
