- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the...preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.GxP Quality System… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... most technically complex formulation and process development through process tech transfer, scale-up activities, quality investigations, change management,… more
- Segula Technologies (Wichita, KS)
- …aircraft structures and/or systems and are responsible for the creation of quality solutions on time from a Design point of view. Duties include performing ... performance, and supporting clients throughout the product lifecycle. With expertise in design, manufacturing, testing, and project management, Segula helps… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within ... Vault RIM)Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance, performance and adherenceWork with the data/ systems SMEs to… more
- Novo Nordisk Inc. (Durham, NC)
- …Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...improvements. Develop plans to improve the performance of a process or set of systems , using green… more
- Novo Nordisk Inc. (Durham, NC)
- …in Windows based operating systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Own self development & initiative to understand the site process control systems , data management systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities ... documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide expertise and solutions to issues regarding… more
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process , Multiple Therapeutic ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams ... 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system... (SCADA, DCS, PLC, HMI) from a software integration perspective. Expertise in computer system validation (CSV) and… more
- Merck & Co. (Rahway, NJ)
- …such as master inventory lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits ... change management and deviation management.Experience supporting internal and external quality audits.Experience in instrument computer system validationTag:… more
- Aequor (Athens, GA)
- …with ability to investigate and troubleshoot issues. Interprets and reviews utility, process system / equipment, plumbing, ductwork plans, architectural, and HVAC ... team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in...to Saturday - 2nd Shift (4pm to 12:30am) Onboarding process : First week: Monday to Friday - ADM -… more
- Merck & Co. (Rahway, NJ)
- …System , Inventory Management, Key Performance Indicators (KPI), Management Process , Materials Requirements Planning (MRP), Medical Supply Management, Portfolio ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Merck & Co. (Rahway, NJ)
- …, Inventory Management, Key Performance Indicators (KPI), Management Process , Materials Requirements Planning (MRP), Portfolio Management, Project Management, ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Merck & Co. (Rahway, NJ)
- …testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support ... Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …refrigeration, pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and ... EPA, OSHA and DEA)HVAC operation, building automation and environmental monitoring systems , process maintenance, instrumentation, automation PLCs, VFDs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Merck & Co. (Durham, NC)
- …driving manufacturing excellence in a fast-paced environment. Utilize your engineering expertise and leadership skills to empower teams, solve complex technical ... 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… more
- AUROBINDO (Durham, NC)
- …very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control ... in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a...and conduct the new hire orientation and exit interview process .Conduct training on new and existing programs, eg workplace… more
- Aequor (Thousand Oaks, CA)
- …(eg, EDC systems , data integration platforms, data flow). Participate in system design, and user acceptance testing. Role model with staff on new technologies ... or interviewed job seekers) Remote- open market rate Purpose: To provide expertise in data management processes, demonstrating capabilities & new ways of working,… more
