- IQVIA (Durham, NC)
- …+ Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring ... master dataset specifications and correct interpretation of protocol, analysis, and CDISC compliance requirements. + Ensures study level ADaM datasets are in … more
- GRAIL (Raleigh, NC)
- …when applicable. Strict adherence to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In ... with other maintenance and technical trades, contractors, engineers, metrology, validation, and quality to help keep these systems operational while adhering to GxP/… more
- ThermoFisher Scientific (Greenville, NC)
- …company, not limited to PV operations, training development, business objectives, quality initiatives and management, process improvement, compliance , and ... programs. + Serves as the primary point of contact for activities related to quality and reporting compliance of safety reports, and as subject matter expert… more
- Burns & McDonnell (Charlotte, NC)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... experience to complex projects, and find's/develops non-standard design solutions. + Quality review production drawings for a variety of projects and project-related… more
- J&J Family of Companies (Wilson, NC)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Control **Job Category:** Professional ... + Author SOP's, Work Instructions and protocols. + Responsible for the quality control laboratory equipment lifecycle management and CSV support. + Participate in… more
- Catalent Pharma Solutions (Greenville, NC)
- …Greenville site. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and ... vendor safety, new hire orientation, job site audits, and ensure regulatory compliance across environmental, health, and safety domains. + Ensure adherence to EPA,… more
- Sumitomo Pharma (Raleigh, NC)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… 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...better life for all. We believe in improving the quality of life for those we serve and contributing… more
- Sumitomo Pharma (Raleigh, NC)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …by maintaining the equipment to perform as designed thereby delivering a quality product. + Performs, documents, and improves procedures and Preventative Maintenance ... Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and...to maintenance and reliability is communicated and/or documented for compliance , history, and reliability. + Strive towards continuous improvement… more