- Aequor (Thousand Oaks, CA)
- …This role will own the execution of the implementation plan in terms of project management and change control execution. This role will apply project ... The Supply Chain Project Manager (SCPM) will translate product variation strategy...areas Assure timely and fully compliant (RFT) maintenance of Change Control Management system related… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …minimum of five (5) years' experience in an engineering or technical discipline Project management experience with emphasis on within IT &/or Manufacturing ... Automation ie, PAS-X Project Management Professional PMP and/or Disciplined Agile...systems Expert in cGMP documentation practice & understanding of change control processes Expert understanding of validation/system… 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
- 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
- Aequor (Seattle, WA)
- …Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting. ... fast pace with cross functional departments to finalize time-sensitive deliverables. Possess project management skills. Experience interacting with FDA or other… more
- Merck & Co. (Rahway, NJ)
- … project management skills to perform and manage the following tasks: Project planning, initiation, execution, change control , and closing. Project ... design and development, with at least 1 year experience working with formal project management tools and processes.ORAssociates Degree with at least 5 years'… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis, strategic planning, internal reporting, ad hoc reporting and analysis, and change management initiatives. Also responsible for expense or headcount ... in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other functional...analytics for resource planning in US and EU.- Special Projects/ Change Management - Accountable for the development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required in technical discipline: Engineering, science or similar field. Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of ... project management experience in the pharmaceutical industry...members. Strong analytical, problem solving and critical thinking skills. Change management . Excellent organizational and communication skills.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Effectively uses and communicates key findings and presents recommendations to senior management .Special Projects/ Change Management - Create and maintain ... the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has… 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. (Durham, NC)
- …site, divisional or regulatory audits/inspections.Good oral and written communication skillsProject management , including change control and equipment ... creating and managing all profit plans and forecasts throughout the year PROJECT MANAGEMENT Responsible for major equipment related projects, including funding,… 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
- 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
- Aequor (New Brunswick, NJ)
- …changes, designs and executes required premarket stability program in support of the change Perform change control impact assessments and document the ... Must Haves: 8&plus years of experience in Stability Program Management for small molecules (oral and sterile product) Strong...stability assessment in change controls. Review and endorse change controls… more
- Merck & Co. (Durham, NC)
- … execution. Provide production shop floor support as needed.Application of sound project management techniques to meet schedule, budget, benefit realization and ... other project objectives.Provide technical guidance/support including authoring or review and...review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs),… more
- Merck & Co. (North Wales, PA)
- …or data integration enhancements per agreed timelinesEstablishes and provides oversight of Change Control Board (CCB) to coordinate and prioritize between our ... oral and written communication skills in an international environment.Excellent project management and organizational skills:Strong leadership skills that… more
- Novo Nordisk Inc. (Durham, NC)
- …tools within the main areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that ... Position Work with team and vendors to ensure process control systems for new equipment and processes are in...on risk management & mitigation Implement effective change management Support Corporate, IFP, local IT,… more
- Novo Nordisk Inc. (Durham, NC)
- …& approves documentation for Quality approval - components/raw material, batch records, change control requests, deviations & validation documents Performs QA ... Position Performs quality review & approval of Batch Production Records (BPRs), Change Requests (CR's), Deviations & other documentation (in conjunction with LoB) &… more
- Tris Pharma (Monmouth Junction, NJ)
- …reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for ... Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality, compliance, productivity, yield, and cost. Implement process improvements within the change control system. Recognize and act on potential compliance ... events and key process parameters and provides reports to management on trending, and status as requested. Identify and...compliance and technical feasibility of proposed changes. Serve as project manager for the change process and… more
