- ICON Clinical Research (Salisbury, NC)
- …of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering ... to work \#LI-SB4 \#LI-onsite **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse… more
- Sumitomo Pharma (Raleigh, NC)
- …specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- ITG Brands (NC)
- …& drive continuous improvement in manufacturing processes and product quality , supporting GSC's manufacturing footprint and leveraging learnings and best ... regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations &… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of… more
- Norstella (Raleigh, NC)
- …data and align insights with client needs. + Monitor and troubleshoot data quality issues, ensuring the integrity and reliability of insights provided to clients ... while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions and helping… more
- Fortrex (Clinton, NC)
- …safe and sanitary environment, apply now to contribute to our mission of delivering top- quality products. **WHO WE ARE:** + Leader in food safety solutions for both ... 450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente… more
- HCA Healthcare (Asheville, NC)
- …including, but not limited to HSPA, CBSPD, AORN, The Joint Commission, FDA , CDC, OSHA, and AAMI. **What qualifications you will need:** Preferred Education: ... the top 1% of hospitals in the nation for providing the highest clinical quality year over year. Leapfrog Hospital Safety Grade recognized Mission Hospital with an… 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 Manufacturing Directions. + Ensures the most recent information related… more
- CSL Plasma (Winston Salem, NC)
- …donor disconnect. + In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates ... necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... adapt to rapidly evolving situations and needs + Strong commitment to delivering high- quality work and upholding HCUS values. + Proficiency in Microsoft Word, Excel,… more