- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main responsibility is to ... cycle of a product. -Key responsibilities include the following: Partner with the Design Control and Risk Management leads to determine the data… more
- Merck & Co. (Rahway, NJ)
- …individual will be expected to apply his/her knowledge of product development, design control principles and risk management techniques to positively support ... Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's Device Development (DD) Team designs,… more
- Merck & Co. (Durham, NC)
- …Systems Applications and Products, Track wise and/or Global Laboratory Information Management System #MSJRNOTICE FOR INTERNAL APPLICANTSIn accordance with ... of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for vaccines.The Specialist, Quality Control participates in a team of analysts in the development, validation, ... lab initiatives, have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit… more
- Merck & Co. (Rahway, NJ)
- …and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively ... Management (CPM)Six Sigma Master Blackbelt certification, or equivalentChange Management or Strategy Realization Framework CertificationNOTICE FOR INTERNAL … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and Compliance GxP processes including audits, regulatory intelligence, regulatory inspections, change management , and quality risk management and support ... CSV/CSA and GxP validations, ensuring seamless integration across platforms. Risk Management : Implement and manage a ...to ensure effective IS management and compliance.Change Management : Establish and manage change control processes… more
- Merck & Co. (Rahway, NJ)
- …by Design (QbD) activities and lead discussions on process and analytical risk assessment.Proactively initiate technical reviews within AR&D and serve as the ... reviews.Develop and maintain a central repository for knowledge and life-cycle management of the program to support regulatory filings.Required Experience and… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation… more
- Insmed Incorporated (San Diego, CA)
- …expert QA review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems. Identify improvement ... GMP analytical records. Will also provide QA support for GTx Quality Control laboratories. This position is onsite/hybrid and based in San Diego,… more
- Merck & Co. (Durham, NC)
- …including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. Second (2nd) shift, Monday thru Friday 2:00pm - ... support on batch review, alarm response, incursion response and deviation management .Provide QA shop floor support on Aseptic techniques, aseptic observations,… more
- Merck & Co. (North Wales, PA)
- …and drive change in the business and teams. Experience with lifecycle management strategies NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy ... landscape. This includes planning and execution around products selected for price control as part of the Inflation Reduction Act, state Prescription Drug… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)-Clean-In-Place (CIP)… more
- Merck & Co. (Durham, NC)
- …osmosis skids, compressed gas systems) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))- Clean-In-Place (CIP) Systems- ... and safe maintenance and repair of equipment using Hazardous Energy Control Procedures Required to wear personal protective equipment including safety glasses,… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... WFI stills, Clean steam generation) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- Merck & Co. (Millsboro, DE)
- …compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP ... as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, DNREC, etc.) of animal… more
- Merck & Co. (Durham, NC)
- …and development of standard work.Experience with Agile or Project Management certificationNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' ... projects and systems such as Programmable Logic Controllers, Distributed Control Systems and Original Equipment Manufacturer platforms.Initiate and lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data ... responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of pre-clinical, clinical, and...and communicate to management .Require minimal direction to complete tasks, knows how to… more
- Merck & Co. (Rahway, NJ)
- …potent compounds, biological, noise, ergonomics, IAQ) and recommends proper control strategies to manage identified risks.-Completes industrial hygiene and biosafety ... corrective and preventive action plans.Reviews processes, facilities, procedures and management of change documents to assure conformance to recognized EHS… more
