- Merck & Co. (Rahway, NJ)
- …Management Process, Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems , Quality ... and/or regulatory inspections. Independently performs audits of batch documentation, data, information , procedures, equipment and systems , and/or facilities to… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical Quality Assurance (CQA) serves ... role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position...and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice… more
- Merck & Co. (Rahway, NJ)
- …control, security certification such as Certified Professional Accountant (CPA), Certified Information Systems Auditor (CISA), Certified Internal Auditor (CIA), ... medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added independent and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...to complete tasks, know how to get resources and information from established internal contacts, and consult with supervisor… more
- Merck & Co. (Rahway, NJ)
- …Adaptability, Administrative Policies, Capital Projects, Collective Bargaining, Compliance Assurance , Computerized Maintenance Management Systems (CMMS), Digital ... and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. -...Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and antibodies in drug discovery and development, manufacturing, and quality assurance . The Laboratory Support Specialist will provide support both at CTI/Repligen… more
- Eisai, Inc (Raleigh, NC)
- …Raleigh facility. This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and ... with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation, and reporting of quality goals and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Repligen (Waltham, MA)
- …logging of issue details, affected part numbers, quantities, and supplier information .Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring ... appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality, or related technical… more
- AUROBINDO (Durham, NC)
- …and training initiatives.HR Reporting & SystemsMaintain and update HRIS (Human Resources Information Systems ).Prepare reports on HR metrics such as turnover, ... of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- Required Master's Degree in Computer Science, Life Science, Engineering, or Information Systems - Preferred Experience10+ years of experience in GxP-regulated ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- BioAgilytix (Durham, NC)
- …build the rules, processes, and cloud pipelines that keep lab and business information accurate, secure, and easy to find. That means hands-on work designing Azure ... quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements,… more
- Aequor (Houston, TX)
- …most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents (ie SOPs, ... the scope of their role under guidance of supervisor/manager o Generously shares information and knowledge with others across the team o Routine interaction with… more
- Eisai, Inc (Exton, PA)
- …with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program Management departments.The Associate ... cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and other internal (PST) and… more
- Merck & Co. (Rahway, NJ)
- …Compliance, Incident Management, IT Business Solutions, Management Process, Management System Development, Problem Management, Quality Assurance (QA), Resource ... our Company's manufacturing division.Understanding of the existing IT portfolio of systems and products.- Understanding of the external technology landscape and the… more
- Repligen (Hopkinton, IA)
- …Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.Ability to communicate with multiple departments and associates.Shares timely ... actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for inspecting, auditing and...information with peers on daily progress.Ability to contribute to… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability… more
- Aequor (Hicksville, OH)
- …using scanning guns. Sets up electronic marquees indicating the product information for production lines. May calibrate scales/checkweighers daily or when moved ... on operator performance. Interacts with production management, mechanics, and Quality Assurance . Participates in training of new employees. Adheres to all applicable… more
- AUROBINDO (Durham, NC)
- …of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several ... /Warehouse, for this Generic Pharmaceutical Company.ResponsibilitiesReceive materials and conform the information in the packing slip and issued PO Store API,… more
