- 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
- 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
- Harlow Aerostructures LLC (Wichita, KS)
- …Participates in frequent and detailed recurrent training courses covering aerospace systems and requirements, company operations policy, etc Performs other related ... diploma or GED 5+ years of experience in quality assurance in aerospace manufacturing 2+ years in leadership role...acquisitions and upgrades as well as new management information systems as an integral part of our annual capital… 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
- 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
- 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
- Merck & Co. (Durham, NC)
- …monitoring during processing and records results in the computerized database system . Provides timely delivery of samples and other materials as required ... Operations, Manufacturing Processes, Operations Support, Pharmaceutical Production, Pharmaceutical Quality Assurance , Production Operations, Production Scheduling, Safety, Health, Environment and… 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
- 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
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical staff to ... site-specific projects related to combination products and drug delivery systems .Facilitate the professional development and performance of team members, fostering… 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
