- 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
- Merck (Durham, NC)
- …and products needed to support manufacturing. + Operates various computer -controlled process support/process equipment (ie washer, autoclave, vial filler, ... + Completes in-process testing and inspections supporting the vaccine manufacturing, validation , and development processes as required. + Identifies and addresses… 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
- Lilly (Durham, NC)
- …+ Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and ... team. + Promote a culture of compliance aligned with internal and external computer system quality standards. + Advocate for quality improvement practices in EBR… 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
- ITG Brands (NC)
- …needs. + Coordinatequalification/validationtesting + Maintains project data base by writing computer programs, entering and backing up data + Lead the development ... regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations &… more
- J&J Family of Companies (Wilson, NC)
- …laboratory equipment lifecycle management including Analytical Instrument Qualification (AIQ) and Computer System Validation (CSV), among others. + Perform ... + Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of… more
- Teleflex (Morrisville, NC)
- …for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a best-in-class, ... * Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination of education...objectives * Strong communication skills * Experience in an FDA regulated environment preferred * Project Management and/or Lean… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …proceed with proper decision making + Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... scheduled or required to maintain systems in a validated state + Perform computer applications Perform other duties as assigned by Management Education, skills and… more
- Sumitomo Pharma (Raleigh, NC)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more