- Novo Nordisk Inc. (Plainsboro, NJ)
- …Excellent skills in designing and implementing innovation/improvement initiatives, including the required change management Project Management experience ... , team collaboration, training and development, employee engagement, and recognition Change management : Identifying areas for improvement in operational… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and finalizing completed projects related to drug product processes, major equipment, and change controls by supporting the Project Manager(s). Job ... timelinesAs applicable, initiate drafts with SME's, track action items, and monitor change controls within the electronic documentation database system. Provide … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the project ; timelines, project updates and budgetary considerationsMonitor change of scope management and trackingManage an appropriate number of active ... are met, budgets are maintained, and action items are completed for projects. The Project Engineer applies project management practices and processes to… more
- Novo Nordisk Inc. (Durham, NC)
- …for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination ... standing with stakeholders through engagement & positive cooperation Perform & oversee change control activities for QC equipment & systems Support systematic… more
- Eisai, Inc (Nutley, NJ)
- …IT compliance policies based on regulatory changes.Establish a regulatory change management process for modifying technological functions and ... compliance controls .Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …treatment and adverse events related to our developing assetsThis role requires project management skills to oversee this complex, cross-functional workstream ... planning and optimal execution of plansOther related assignments may include project management , process improvement, tool generation (checklist, process map,… more
- Novo Nordisk Inc. (Boulder, CO)
- …of QA Specialists ensuring the tactical execution of the internal and external (CMO) change control and deviation processes at NN Boulder, specifically in the ... as well as through other functions and routine networking opportunities. Essential Functions Change Control : Develops and maintains the Change Control… more
- Merck & Co. (Durham, NC)
- …of regulatory inspections by presenting and defending technical documentation, investigations, and change controls Helps to establish empowered teams to achieve ... authoring technical documentation within a cGMP context (protocols/reports, investigations, and/or change controls ) Proven leader with influence and outstanding… more
- Merck & Co. (Rahway, NJ)
- …design, build, implementation prep, implementation, hyper care).Lead for change management for PMO enhancements impacting Development Project Management ... leaders through organizational alignment and integrated planning and execution. The Project Management Office (PMO) within GPAM enables pipeline progression… more
- Merck & Co. (Rahway, NJ)
- …GMP clinical production. -Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and IT ... teams.Establish GxP systems in the facility: Change Management , Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation… more
- Merck & Co. (North Wales, PA)
- …improve human health and the business. -Under GPAM, the CMC Integrated Project Management organization (CIPM) serves on the Development and Commercialization ... developing and executing an asset's CMC (Chemistry Manufacturing & Controls ) strategy. This is a growing organization that was...new team.Reporting to the Executive Director of CMC Integrated Project Management , the core responsibility of this… more
- Catalent (Harman, WV)
- …follow GMP regulations.Ensure that all project work is managed under GMP Change Control where required and that this is incorporated into timelines.Ensure ... Control Associates and Materials Services Associates. Responsibilities include: project participation, dashboarding, reporting, and governance. The scope includes… more
- Merck & Co. (Durham, NC)
- …team members.Review and approve documents as necessary including investigations, change controls , SOPs, validation protocols, technical reports.Makes decisions ... and current industry trends. Preferred Experience and Skills: Knowledge of Supplier Management and Incoming ReleaseDemonstrated Project Management Experience… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …minimal supervision Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management , Quality Control , Facilities, and Quality ... equipment improvement programs, investigates deviations, and implements corrective/preventative actions via change requests, document change controls , and… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position ... Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation… more
- Merck & Co. (Rahway, NJ)
- …with data and to use the data to drive decisions on programs improvements.Support project management activities (manage project plans, track, and follow-up ... Utilities procurement including Category Strategy Development, Strategic Sourcing, Supplier Relationship Management , Project Management , and a good… more
- Catalent (St. Petersburg, FL)
- …for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control .The QA Product Manager provides customer service, with the ... review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to… more
- Novo Nordisk Inc. (Durham, NC)
- …& approves documentation for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA ... quality oversight & on floor production support required Knowledge in Quality Management Systems Demonstrated knowledge of critical controls & input/output… more
- Tris Pharma (Monmouth Junction, NJ)
- … Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change controls and updating specifications to reflect changes in methods. ... reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for… more
- Merck & Co. (Durham, NC)
- …plansWriting and maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and ... Project EngineersAids in the development of SOPs, engineering change requests, preventative maintenance plans/calibration procedures, task lists, etc.Ensures… more
