- Merck & Co. (Durham, NC)
- …gowning qualifications, and sterility assurance compliance, and facility environmental requalification activities.- Position Responsibilities :- Report to the ... transition to commercial manufacturing assignments.- Support Sterility Assurance (SA) Environmental Monitoring (EM) monthly and annual trending report preparation… more
- Merck & Co. (Durham, NC)
- …development processes as required . - Identifies and addresses compliance, environmental , safety, and process deviations as appropriate and escalates to appropriate ... prepares equipment used in vaccine manufacturing process. Schedules and performs environmental monitoring during processing and records results in the computerized… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the US Sustainability leader and will 1) manage the US Environmental Social Governance (ESG) Sustainability initiatives and partner with colleagues in Japan ... disclosure reporting and ESG auditing.Responsibilities- Manage and Support US Environmental , Social, Governance (ESG) Sustainability Initiatives and greenhouse gas… more
- Merck & Co. (Durham, NC)
- …average cell dry weight testingConducts microbiological testing; evaluation of environmental microbiological samplesConducts environmental monitoring sampling to ... in alignment with department objectivesConducting In-Process and Release testingConducting Environmental Monitoring of processes and on a routine basisProblem… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …management, (ie, QC-Microbiology Supervisor) and will provide both laboratory and/or environmental monitoring leadership as part of the Microbiology group. The ... incumbent will participate in technical planning of day-to-day lab and environmental monitoring activities, and will be responsible for establishing testing and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Microbiologist I will perform Microbiological laboratory testing associated with Environmental Monitoring (EM), Water for Injection (WFI), and product specific ... Microbiological samples. Additionally, the Microbiologist will be trained to perform Environmental Monitoring (EM) and Water for Injection (WFI) sampling in support… more
- Merck & Co. (Rahway, NJ)
- …on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements in addition to the existing labor contract to meet SSO ... responsible for implementing process improvement actions to meet S&E (Safety & Environmental ) and GMP requirements.- This position is also responsible for ensuring… more
- Merck & Co. (Durham, NC)
- …full manufacturing process, process requirements and inputsManage and evaluate environmental monitoring trends and data for continuous improvementPrioritize and ... 2 years in a quality function that supports compliance, release and/or environmental monitoring supporting a GMP manufacturing facility.Working knowledge of GMP and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This newly ... gas sampling to support manufacturing and/or qualification activities. Perform environmental monitoring such as viable air, total particulate air (non-viable),… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …leading a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This role ... compressed gas sampling to support manufacturing and/or qualification activities.Perform environmental monitoring such as viable air, total particulate air… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration ... (eg EPA, OSHA and DEA)HVAC operation, building automation and environmental monitoring systems, process maintenance, instrumentation, automation PLCs, VFDs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy ... program.Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.Perform peer review/approval of laboratory data.Utilize electronic… 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 ... excursions, deviations, and sterility failures. The individual is expected to coordinate project execution and to work alongside Sterility Assurance, Quality, and Operations personnel to ensure execution. The primary responsibility is to maintain sterility… more
- Novo Nordisk Inc. (Durham, NC)
- …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 case-by-case basis based on the role. Qualifications Bachelor's degree in… more
- Novo Nordisk Inc. (Durham, NC)
- …standards, & specifications to fulfill customer needs Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned ... Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …studying the pathogenesis of infectious agents and toxicity of environmental pollutants and drug products.QualificationsBachelor's Degree in Medical Technology or ... related field and one year experience as a laboratory generalist, or MLT with two years' experience in a clinical laboratory, or an equivalent combination of education and training from which comparable knowledge, skills and abilities have been… more
- Merck & Co. (Durham, NC)
- …and supports all Good Manufacturing Practices (GMPs), safety, and environmental regulations.-Participates in investigations of automation incidents and problems to ... prevent recurrence including the development and implementation of corrective actions.Over time, become a subject matter expert (SME) in specific process steps, automation technology platforms, and specific systems.Over time, becomes expert practitioner of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on a) thorough analysis of internal and external business issues and environmental factors b) careful assessment of available data and determination of knowledge ... gaps c) translating data into insights with business impact Lead development of assigned market research plans in conjunction with Director, CI&A and incorporate needs and opportunity assessments with Brand Leads; Consult with brand teams on proper focus and… more
- Merck & Co. (Durham, NC)
- …process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.Will support and prepare Set-up ... Activities for SFQA First Shift (Days).Support Operations and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality… more
- Merck & Co. (Durham, NC)
- …cost, or lower our processing cycle times. Supports team safety, environmental , and compliance objectives. Manages project and investigation timelines to ensure ... key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible. Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, and Planning. Education Minimum… more
