- Merck & Co. (Rahway, NJ)
- …Management Process, Manufacturing Processes, Manufacturing Quality Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems , Quality ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This role ... and leverages relationships with HQ SMEs, process management, and system management to influence process and system ...and system management to influence process and system development in a manner consistent with global affiliate… more
- Aequor (Thousand Oaks, CA)
- …communication skills Time management Proficient computer skills (ie documentation systems , databases and spreadsheets). Bachelor's degree OR Associate's degree and ... 4 years of directly related experience OR High school diploma / GED and 6 years of directly related experience Preferred Qualifications: Bachelor's Degree in Science OR Associate's Degree in Science and 3 years of experience in biotechnology/Pharma… more
- Aequor (Thousand Oaks, CA)
- …industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the ... in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic batch record review,… 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)
- …medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added independent and ... risk-based audit and assurance services.Position Overview / Function and ResponsibilityThe Associate Director:Leads a small team through financial and compliance… 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...working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality, or cell therapy.GxP Quality… 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
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the… 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)
- …appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality, or related technical ... of experience in supplier quality engineering, manufacturing engineering, or quality assurance . Proven experience with ISO 9001 audits and supplier quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering NNI Provides ... and leverages relationships with HQ SMEs, process management, and system management to influence process and system ...and system management to influence process and system development in a manner consistent with global affiliate… 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 ... and producing reports, as needed. (currently utilizing Paylocity as our HRIS system )Assist in talent acquisition and recruitment processes by creating and posting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global ... systems , electronic records, validation processes, and regulated applications meet...Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional Global DX… more
- BioAgilytix (Durham, NC)
- …quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… 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, ... with others across the team o Routine interaction with Quality Assurance (Raw Materials) and other interdepartmental members to communicate investigational current… more
- Repligen (Waltham, MA)
- …industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and ... revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality focus; build, maintain,… more
