- 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 ... principles. + Promote a culture of compliance aligned with internal and external computer system quality standards. + Comply with the organization's safety goals and… 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 ... + Promote a culture of compliance aligned with internal and external computer system quality standards. + Comply with the organization's safety goals and… 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
- 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
- Novo Nordisk (Clayton, NC)
- …standards + Manage individual training plan + Participate in qualification & validation activities as required + Setup, operate, monitor, & control highly automated ... experience preferred + Minimum two (2) years of manufacturing experience in FDA regulated environment preferred + Experience demonstrating a systematic approach to… more
- Cardinal Health (Raleigh, NC)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… 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, &… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... systems (in a regulated environment within the last 6 years preferred). + Basic Computer Skills required; must be experienced and proficient in the use of Windows… more
- Reynolds American (Winston Salem, NC)
- …+ Regulatory Experience: Experience with FDA -relevant systems and/or processes and computer system validation . **WE ARE REYNOLDS AMERICAN-A member of the ... BRITISH AMERICAN TOBACCO GROUP** At Reynolds American, we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. **See what is possible for you at REYNOLDS AMERICAN.** + Global Top Employer… 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 ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
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