- Northrop Grumman (Linthicum Heights, MD)
- …is seeking candidates for the position of Principal / Sr. Principal Factory Change Control Engineer to support advanced technology development programs. This ... requisition which can be filled as a Principal or Sr. Principal Factory Change Control Engineer What You'll get to Do: Create procedures and best practices for… more
- Bausch Health (Bridgewater, NJ)
- Pharmaceutical Change Control Process Owner Job Location: Bridgewater, New Jersey, USA Job Requisition ID: 13640 Join our global diversified pharmaceutical ... progress and impact. The Principal Engineer is responsible for managing the change control process. This role ensures that all changes to processes, systems,… more
- 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
- 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
- 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
- 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)
- …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
- 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
- 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. (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
- ABM Industries (Newark, NJ)
- …capacity and environmental conditions Ensure compliance of Customer SLA parameters and Change Control activities, review and approve all system changes ... are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. ABM offers a comprehensive benefits… more
- Thermo Fisher Scientific (Middletown, VA)
- …Adobe Sign / Electronic Software. Maintain and update spreadsheets and Smartsheet related to change control , management of change and change ... Middletown, VA Specialty Diagnostic Group (SDG) Position Summary The Document Control Administrator is responsible for editing and reviewing documents that impact… more
- Cytiva (Duncan, SC)
- …process performance and improve outcomes. Support non-conformance, investigations,CAPAs, and change control processes related to contamination controls and ... the Danaher Business System which makes everything possible. The Contamination Control Specialist is responsible to provide expertise and oversight for sterility… more
- Rohrer (Huntley, IL)
- At the beginning of the shift change , the Quality Control Auditor is responsible for: Arrive 5 minutes prior to shift to receive production updates from previous ... machines that will be running on the shift. During 'Setup' Operation, Quality Control is responsible for: Read and understand the requirements of the production… more
- Infosys (Chicago, IL)
- …the CRQs Manage Audit Trails Support SOX Audit / Compliance Create and maintain Change management process control documentation Provide all the Charm and Remedy ... Job Description Infos ys is seeking a Lead SAP Change Management Consultant This position requires an expert contributing...a consultant having 7+ years of experience in SAP Change Management lead . The Individual will require to… more
