- Cardinal Health (Greensboro, NC)
- …(Human Resources, Transportation, Sales, Finance, and Safety) + Enforce Cardinal Health compliance and regulations for OSHA, DEA, FDA , state and local ... satisfaction. In addition, this leader will lead the distribution center's compliance with all appropriate state and federal agencies. **Responsibilities** + Provide… more
- Sumitomo Pharma (Raleigh, NC)
- …cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First" ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Kelly Services (Greenville, NC)
- …regulatory requirements. This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and ... documentation is completed in accordance with Good Documentation Practices (GDP). **3. Compliance and Quality Assurance:** o Ensure all deviations are managed in … more
- Teleflex (Morrisville, NC)
- …projects and ensure appropriate data collection for regulatory submissions and compliance . * Review and assess change control activities for potential impact ... on current regulatory filings. * Ensures compliance with design controls, reviews design documentation to ensure...audits to mitigate any potential risks. * Interface with FDA , Notified Bodies, or other national health agencies regarding… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and ... relate to process, computer systems, and equipment validation. + Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective… more
- Sodexo (Greensboro, NC)
- …EO, hydrogen peroxide, and ozone-based systems + Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed ... role that plays a critical part in ensuring safety, compliance , and equipment uptime in healthcare environments. **What You'll...service documentation and logs for compliance and reporting + Respond to on-site service requests… more
- Sumitomo Pharma (Raleigh, NC)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Fujifilm (Holly Springs, NC)
- …managing equipment, vendors, and daily operational activities while ensuring compliance with safety, regulatory, and Good Manufacturing Practices (GMP) standards. ... to minimize downtown, and ensures equipment operates efficiently while adhering to compliance and safety standards + Performs inspections and analysis to identify… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …+ Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs Quality + Ensure that all batch ... document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations + Provide assistance with… more
- ThermoFisher Scientific (Greenville, NC)
- …regulatory requirements. This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and ... + Ensure that documentation is completed following Good Documentation Practices (GDP). ** Compliance and Quality Assurance:** + Ensure all deviations are managed in … more