- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance… more
- Capital One Bank (Wilmington, DE)
- …support reporting for risk metrics Develop risk analysis, perform deep dive investigations , and drive specific risk initiatives to minimize risk posture and ... strengthen overall control suite effectivenessDesign and support internal risk and control governance processesIdentify and implement continual risk program enhancements based on industry standards and best practices in alignment with Capital One's strategic… more
- Capital One Bank (Wilmington, DE)
- …pivotal technology risks and required actions.Perform in-depth risk analysis and investigations , driving specific risk initiatives to minimize overall risk posture ... and enhance the effectiveness of the control suite.Collaborate with technology leaders to ensure appropriate management of technical Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs).Identify and implement continuous enhancements to the… more
- Capital One Bank (Wilmington, DE)
- …support reporting for risk metrics Develop risk analysis, perform deep dive investigations , and drive specific risk initiatives to minimize risk posture and ... strengthen overall control suite effectivenessDesign and support internal risk and control governance processesIdentify and implement continual risk program enhancements based on industry standards and best practices in alignment with Capital One's strategic… more
- Capital One Bank (Newport News, VA)
- …risks and actions neededDevelop and monitor risk analysis, perform deep dive investigations , and drive specific risk initiatives to minimize risk posture and ... strengthen overall control suite effectivenessSupport Risk Control and Self Assessments (RCSAs)Understand, document, and analyze current state capabilities leveraging one or more risk methods. Leverage industry benchmarking to determine best practices and… more
- Aequor (Irvine, CA)
- …stakeholders to achieve company objectives, leading technical root cause investigations , developing and executing risk-based decisions, resolving and documenting ... customer complaint and manufacturing investigations , and representing Quality in cross-functional projects. Job Duties: Develops and executes plans for quality and… more
- Capital One Bank (Newport News, VA)
- …reporting for technology risk metrics Develop risk analysis, perform deep dive investigations , and drive specific risk initiatives to minimize risk posture and ... strengthen overall control suite effectivenessDesign and support internal risk and control governance processesIdentify and implement continual tech risk program enhancements based on industry standards and best practices in alignment with Capital One's… more
- Aequor (Thousand Oaks, CA)
- …quality records as owner (such as deviations, change control, supplier investigations /etc. Preferred experience managing in Track Wise or Veeva Systems Basic ... Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This… more
- Merck & Co. (Rahway, NJ)
- …lead and support facility operations, process development activities, compliance investigations /change management, authoring of GMP documentation, and lead other ... GMP activities and deliver training as needed. Support deviation investigations , corrective/preventative action closures, and building initiatives as appropriate.… more
- AUROBINDO (Durham, NC)
- …and presents data to support and document product development decisions. Leads investigations to support product and method optimization. Supports investigations ... of sample collection methods.Will troubleshoot methods and conducting laboratory investigations . Prepare SOPs, protocols, and reports. Performs studies according to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …platforms, including MES, SAP, Track Wise, and eLIMS.Initiate product non-conformance investigations and deviation investigations in Track Wise as necessary ... Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issuesRequirementsPosition requires a 2-yr Associate Degree. Will consider experienced candidates with a high school diploma or… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance. Additionally, the role ... highly regulated environment.Key Responsibilities Lead manufacturing and cross functional investigations from end to end.Ensure thorough root cause analysis, impact… more
- Merck & Co. (Rahway, NJ)
- …anticipate, and solve significant scientific and technical challenges.Lead complex investigations into technical challenges related to design, manufacturing, and ... to grow their technical rigor to lead and/or contribute to investigations and resolutions.Cross-Functional Collaboration:Act as the primary technical advisor for all… more
- Merck & Co. (Rahway, NJ)
- …community. The COE teams provide support to life cycle changes, investigations , trouble shooting and continuous improvement initiatives to guarantee the robustness ... to the portfolio.- This includes above site support for significant investigations , developing new solutions, establishing guidance and standard work. and… more
- Eisai, Inc (Exton, PA)
- …The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs and ... The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs and… more
- Merck & Co. (Rahway, NJ)
- …pillars of Global Development Quality for the purposes of investigations , corrective action/preventive action, procedural controls, auditing and Quality Risk ... Adaptability, Audit Management, Automated Manufacturing Systems, Biopharmaceutical Industry, Compliance Investigations , Computer Science, Configuration Management (CM), Deviation Management, Document… more
- Eisai, Inc (Nutley, NJ)
- …to senior business leaders and collaborate on remediation strategies Support investigations by conducting data reviews to identify potential compliance risks or ... monitoring workflows Utilize compliance systems to support audits and investigations Propose and project manage new system implementations, including vendor… more
- Merck & Co. (South San Francisco, CA)
- …Business Development, Business Management, Clinical Documentation, Clinical Investigations , Clinical Judgment, Clinical Reporting, Clinical Research, Clinical ... Trial Documentation, Clinical Trial Planning, Consultative Approach, Cross-Cultural Awareness, Drug Development, Ethical Standards, Innovation, New Technology Integration, Operational Excellence, Oral Communications, Pharmaceutical Management, Product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and safety stock levels) within the site ERP.Assist with the development of investigations and root cause analyses on any supply disruptions or material quality ... related issues.Support Quality, Regulatory and Financial audits.Provide timely responses to business units' representative(s) and suppliers' inquiries.Assist with the development and implementation of standard operating procedures, work instructions and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and safety stock levels) within the site ERP.Assist with the development of investigations and root cause analyses on any supply disruptions or material quality ... related issues.Support Quality, Regulatory and Financial audits.Provide timely responses to business units' representative(s) and suppliers' inquiries.Assist with the development and implementation of standard operating procedures, work instructions and… more
