- Tris Pharma (Monmouth Junction, NJ)
- …Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), methods, specifications, protocols and ... and reports, as well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required… more
- Twist BioScience (South San Francisco, CA)
- …ensuring user adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree ... both internal development and external services, and demonstrating ROI for MES investments. Change Management: Lead change management efforts related to MES… more
- Eisai, Inc (Exton, PA)
- …deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee ... and close-out of documentation, manufacture of DS/ADI materials, and suite change -over ensuring compliance to relevant regulations. The Associate Director is also… more
- Merck & Co. (Rahway, NJ)
- …influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for problems associated with investigations Completes accurate and timely assessments associated with change control activities Ensures change control ... certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of… more
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .On-floor support of manufacturing activities.Identify and ... member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual… more
- BioAgilytix (San Diego, CA)
- …the development and revision of Computer System Validation procedures and policies (validations, change control , data integrity), following 21 CFR Part 11, Annex ... procedures (SOPs) including those for account management, systems configuration, change control , and incident handlingAdditional ResponsibilitiesAt all times,… more
- Merck & Co. (Durham, NC)
- …solving and troubleshooting Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... be willing to learn multiple CMMS system platforms and route engineering change requests through CMMS system.Expand knowledge into other systems, capable of managing… more
- Aequor (Thousand Oaks, CA)
- …and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or ... customer concern to various levels of management as appropriate. Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per… more
- Merck & Co. (Rahway, NJ)
- …documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation ... Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Adaptability, Business Systems, Change Management, Communication, Cross-Cultural Awareness, Data Management, Employee Training… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation on the platform process description and collaborate to the global change control process and global investigations.Maintain global program project ... process platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Therapy cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES ... solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.Clear and succinct verbal and… more
- Merck & Co. (Austin, TX)
- …PowerShell, and REST APIs.Participate in test planning, safety validation, change control , and rollback design.Document technical implementations, integration ... patterns, and decision logic.Collaborate with engineers and domain owners to identify automation opportunities.Apply cybersecurity understanding to ensure automation is relevant, secure, and impactful.Required Qualifications:1-2 years of hands-on experience in… more
- Merck & Co. (Durham, NC)
- …Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply Chain Management:-Manage coordination with ... End-to-End Product Supply Chain nodes (upstream and downstream) to ensure timely and optimized flow of materials.-Demand Management, E2E Production Planning, Materials Management, Logistics, and SAP Entries as needed. -- Continuous Improvement: -Assess current… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for...cleaning to ensure it is safe ready for use Change out pipet soakers on a weekly basis Receive ... incoming samples Perform inspection of house cleaning checklist weekly Monitor and implement safety procedures as part of lab safety committee Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assessment management Provides SME support to employees working within the quality control process, including consultation on in-process change requests within ... role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from...it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... relevant areas Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP,… more
- Merck & Co. (Rahway, NJ)
- …will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Merck & Co. (Rahway, NJ)
- …to ensure scalable and efficient data models and pipelines.Use GitHub for version control of scripts, data models, and BI artifacts to ensure collaboration and code ... willingness to upskill.Experience with GitHub or similar platforms for version control and collaboration.Understanding of data modeling, ETL processes, and data… more
- Novo Nordisk Inc. (Orlando, FL)
- …programs and services, establish alignment among Endocrinologists around the need for change , the value propositions the new product, program or service represents ... to achieve maximum customer effect and sales volume Prudently control company property consistent with applicable company policies and...it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity… more
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