- Catalent (Harman, WV)
- …of Quality -Maryland is responsible for Quality , Validation and Quality Control and is the most responsible person for batch disposition. The Head of ... Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures is performed on manufactured products.Review and… more
- Merck & Co. (Durham, NC)
- …product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist ... Job DescriptionOur Quality Assurance group ensures all materials inside our...Hybrid work model does not apply to, and daily in- person attendance is required for, field-based positions; facility-based, manufacturing-based,… more
- Insmed Incorporated (Bridgewater, NJ)
- …years relevant experience requiredExtensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.Commercial drug ... York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for ... around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within one or more… 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) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior… more
- Merck & Co. (North Wales, PA)
- …and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.Knowledge and ... It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation… more
- Merck & Co. (Durham, NC)
- …maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance ... and embraces a team culture including significant interaction with operations, quality , automation, technology, and other groupsHVAC/R equipment (air handling units,… more
- Merck & Co. (Durham, NC)
- …or review and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key ... Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible for supporting qualification of Fermentation… more
- Merck & Co. (Rahway, NJ)
- …the project plan are executed on time and with appropriate quality .- Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity ... and manage the following tasks:Project planning, initiation, execution, change control , and closing.Project team development, project team leadership, meeting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …you ready to realize your potential? The Position This position assists with technical, quality and project issues within the Automation team. This person is ... the design, implementation, start-up and troubleshooting of automation and plant floor control systems. Under close supervision is responsible for the design and /… more
- Merck & Co. (Rahway, NJ)
- …Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in ... prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management.Familiarity… 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) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.- Responsible for… more
- Merck & Co. (Rahway, NJ)
- …support several automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment utility metering ... prepare/review Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsEffective interpersonal and communication skills, both verbal and… more
- Merck & Co. (Durham, NC)
- …provides the best in class services with the final goal of delivering our high- quality vaccines to the patients around the world.With our core principle of Safety ... First and Quality Always EMSS strives to have the safest and...Responsible for major equipment related projects, including funding, change control and equipment qualification within their areaResponsible for obtaining… more
- Merck & Co. (Rahway, NJ)
- …needs to CRA-Manager and/or functional vendor and internal management as needed.o Performs Quality control visits as required.Leads local study teams to high ... with-ICH/GCP and country regulations, Our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Merck & Co. (Durham, NC)
- …is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a variety ... of industrial control platforms to manufacture vaccines, including DeltaV, PLCs, MES,...an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- This position is for nighttime… more
- Merck & Co. (Millsboro, DE)
- …and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes ... including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes. This role will consist of these… more
- Merck & Co. (Rahway, NJ)
- …department, within function and cross-functionally.Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial ... guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation.… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. Ability to perform routine… more
