- 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
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Execute processes to ensure systems and/or solution achieve and maintain validation and/or qualification in accordance with regulations and guidance from the… 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
- Mentor Technical Group (Monroe, 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
- ThermoFisher Scientific (Greenville, NC)
- …Staff Quality Control Environmental Monitoring Engineer will coordinate the validation environmental monitoring (EM) programs within our pharmaceutical manufacturing ... EM programs for cleanrooms and controlled environments. + Coordinate EM validation of air, surface, and personnel samples, including microbiological and particulate… 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 ... Ensure compliance with company processes and procedures, as well as applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines. +… more
- Sumitomo Pharma (Raleigh, NC)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- ThermoFisher Scientific (Greenville, NC)
- …requested. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... interpersonal skills, influencing and team building skills + Understanding of guidelines ( FDA , ICH, EMA and GCP) + Working knowledge of biostatistics, data… 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
- ThermoFisher Scientific (Wilmington, NC)
- …sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... detail, process and prioritize sensitive complex information + Proficiency in basic computer applications + Fluent in spoken and written English + Excellent… more
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