- Mentor Technical Group (NC)
- …our Talent Bank. + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...+ Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more
- United Therapeutics (Research Triangle Park, NC)
- …and JCI Metasys experience + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + PLC ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... and routine troubleshooting. + Collaborate with Quality Assurance, Engineering, and Validation teams to support production and resolve deviations. + Adhere strictly… more
- United Therapeutics (Research Triangle Park, NC)
- …procurement and utilization + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- GRAIL (Durham, NC)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and creation of reports, etc + Assist with equipment validation activities associated with CGMP process + Assist with...of CGMP regulations + Applied knowledge of pharmaceutical GMPs, FDA guidelines, and industry standards and the ability to… more
- GRAIL (Durham, NC)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... robust performance across all workflow phases. + Develop, optimize, and document validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485,… more
- Sumitomo Pharma (Raleigh, NC)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** +...& Technical Skills** + Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related field.… more
- Fujifilm (Raleigh, NC)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more