- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager II is responsible for managing larger, more complex projects or multiple projects simultaneously. This role focuses on driving ... the full project lifecycle, developing and implementing project strategies,...in compliance with applicable SOPs, cGMPs, regulatory requirements, safety, environmental , and company policies.Perform other duties as assigned to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager I supports the management of small to medium-sized projects or programs, ensuring they align with business objectives and are ... executed effectively. This role involves supporting project lifecycles through strategic planning, timeline management, and resource coordination while working… more
- Merck & Co. (Durham, NC)
- …reduce cost, or lower our processing cycle times. Supports team safety, environmental , and compliance objectives. Manages project and investigation timelines to ... investigations as required. Work as an individual contributor, team or project lead. Supports and/or executes continuous improvement projects that increase… more
- Merck & Co. (Durham, NC)
- …and Warehouse Operations, and Quality Assurance colleagues as directed in support of Project Flash. This position will support the technical roles of Quality in ... sanitization, gowning qualifications, and sterility assurance compliance, and facility environmental requalification activities.- Position Responsibilities :- Report to the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …quality system interface for Siemens Building Management System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation ... scheduling and financial requirements. Communicate status of projects to applicable project team Project Installation Support: Sub-contractor supervision, BMS… more
- Merck & Co. (Durham, NC)
- …laboratories. - The Quality Assurance Specialist will support this expansion. Project activities requiring support include the process and technology introduction, ... Include: Reporting to the Quality Assurance Organization, will independently manage project assignments. Ensure individually assigned aspects of the project … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …formats. Job Responsibilities: Analyze production and processing problems and initiate project definitions to resolve themDesign or specify equipment to meet ... in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste-related issuesDirect and… more
- Merck & Co. (Durham, NC)
- …applicable.Contributes to the performance and results of the expansion project .Adapts plans and priorities to address resource and operational challenges.Decisions ... (ie, IQ/OQ/PQ).Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.Provides Quality input, direction, and… more
- Merck & Co. (Rahway, NJ)
- …writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, ... other regulatory requirements for CMC.- Strong experience in safety and environmental knowledge and site presence.- -Excellent verbal and written communication… more
- Merck & Co. (Durham, NC)
- …or weekend coverage may be required, based on production schedule, or project -specific assignments to support business needs. Primary Responsibilities: Member of the ... full manufacturing process, process requirements and inputsManage and evaluate environmental monitoring trends and data for continuous improvementPrioritize and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives, asset management, reliability, and business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to ... regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and procedures related to completion of media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring ... deviations, and sterility failures. The individual is expected to coordinate project execution and to work alongside Sterility Assurance, Quality, and Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversee the work of support staff that will assist in the project execution and management of specific research projects. May supervise junior market ... on a) thorough analysis of internal and external business issues and environmental factors b) careful assessment of available data and determination of knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …issues, market analysis, disease areas landscape, and secondary research and environmental factors b) careful assessment of available data and determination of ... data in a compelling and convincing fashion, strong writing, presentation, and project management skills Analytical and strategic thinking - able to see the… more
- Novo Nordisk Inc. (Durham, NC)
- …line with the site Training plan that supports daily operations, as well as project ramp up & Operational Readiness. Communicate data & metrics that inform & support ... schedule with every Friday and Saturday along with Sundays off. Relationships Project Director/Manager. Essential Functions Serve as the training expert in assigned… more
- Novo Nordisk Inc. (Durham, NC)
- …methods and statistical thinking in ET through coaching, training, consultancy, project participation and strategic planning Follow all safety & environmental ... requirements in the performance of duties Other accountabilities as assigned Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. % can change on a… more
- Novo Nordisk Inc. (Durham, NC)
- …Metrology technicians in training, problem solving & improvement project Perform failure investigations (non-conformities) related to Metrology/Calibration process ... standards, & specifications to fulfill customer needs Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned… more
- Merck & Co. (Durham, NC)
- …for Production Support & Media, Drug Substance and Drug Product throughout the project lifecycle.Ensure all aspects of the Shop Floor QA proceed in compliance with ... review, process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.Will support and prepare Set-up Activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand strategy development and execution. Responsible for monitoring market trends, project coordination, and maintaining related tools focused on Novo Nordisk's US ... based on: thorough analysis of internal and external business issues and environmental factors careful assessment of available data and determination of knowledge… more
- HEPCO, Inc. (New Brunswick, NJ)
- …and advising on the best use of resources. The PA will also address project issues, develop solutions to meet productivity and quality goals, and ensure client ... and Trade Ally escalations. Gain an in-depth understanding of project processing, savings methodologies, and best practices. Collaborate with cross-functional… more
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