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Conduct incident investigation based on incident classification and liaise with engineers, management and health and safety regulatory authorities and support in identifying causes of accidents and prevent their recurrence.
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Talent Pool - Administrative & ClericalThe Clinical Research Specialist is a supportive clinical research role that assists in a variety of activities, including work with laboratory specimens, document preparation, record keeping, materials preparation, and review of prospective research participants.
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The candidate will also be expected to handle tasks related to vendor management, calendar management, document review, regulatory compliance, and office operations, including e-filing and e-billing.
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Preparation of responses to Regulatory authorities’ supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.
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Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD.
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Assists in the development, review, and execution of quality management system areas (e.g. change control, document control, risk analysis, design control, verification and validation, etc.
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Serving clients for over 30 years, KLDiscovery offers data collection and forensic investigation, early case assessment, electronic discovery and data processing, application software and data hosting for web-based document reviews, and managed document review services.
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Quality Assurance organization is also responsible for internal auditing, supplier quality management, change management and document/records management, managing regulatory inspections, quality systems oversight and quality metrics reporting.
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Accountable for the credit union’s third party vendor management program and vendor due diligence, insurance and bond coverage appropriate for the organization, contract review and litigation, information and fraud mitigation and prevention program, and information management of member documentation including document imaging, storage and retrieval.
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Interact with BPI partners to facilitate documentation review/exchange, advance project activities and attend project team meetings in absence of the Regulatory Project Lead, as needed. Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations.
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The company supports multinational law firms and corporations by providing identifying and sourcing talented individuals for staffing needs, using innovative software, combining deep legal and regulatory industry expertise and excellent client service.
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Offers data collection and forensic investigation, early case assessment, electronic discovery and data processing, application software and data hosting for web-based document reviews, and managed document review services.
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Test utility systems, execute environmental sampling, provide data entry, review data, summarize test results, support performance qualification activities, monitor personnel, Submit LIMS sample rejections, author and summarize re-qualification, performance qualification, and special study protocols, and document control of logbooks.
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Monitor system for approvals and send engineering responses to SSC rep for technical review. Monitors quality, compliance and regulatory aspects between company and third party manufacturers including relationship management, technical issues, schedule conflicts, quality issues, vendor selection and evaluation.
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Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
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