- Repligen (Waltham, MA)
- …manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate ... issues through appropriate channels, ensuring long-term risk mitigation and product quality assurance .Qualifications Bachelor's degree in engineering, Quality… more
- JobTarget (Yuba City, CA)
- …action was taken to correct any findings found during initial review.Present monthly Quality Control and Assurance findings to Real Estate management.Maintain a ... Ensure all real estate documentation adheres to established compliance and regulatory controls and requirements. Essential FunctionsPerform review of all real estate… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet ... LIMS and ERP systems.Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical… more
- Merck & Co. (Rahway, NJ)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess ... drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables,… more
- Merck & Co. (North Wales, PA)
- …stakeholder requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... aspects of clinical study planning, implementation, data delivery and reporting . Will represent DSPD Clinical Operations in a range...studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , technical ... a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role...for manufacturing issues.Real time review of all documentation, and reporting , in support of process unit operations, in accordance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...OverviewThe QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan… more
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