- Grifols Shared Services North America, Inc (Clayton, NC)
- …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... Ability to work a 24/7 rotating shift schedule. + Comfortable with using different computer systems to perform data entry. + Willingness to work with and learn from… more
- 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
- ConvaTec (Greensboro, NC)
- …(NC) and Corrective Action/Preventive Action (CAPA) system. * Ensures compliance to FDA 21 CFR Part 820, ISO 13485:2016, Medical Device Single Audit Program, ... NC/CAPA activities and documentation to assure compliance with NC/CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review… more
- Lilly (Durham, NC)
- …group supporting asset delivery, process development, operational readiness, start up, and validation of the device assembly and packaging areas. After startup, the ... Flow Team. **Minimum Requirements:** + Bachelors degree in a science, engineering, computer , or pharmaceutical-related field of study. + At least 7 years working… 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
- 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
- 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 ... other applicable regulations (eg privacy, OSHA, etc.). + Demonstrated ability to lead and influence cross-functional teams with a strong customer service focus. + Strong analytical and problem-solving skills. + Highly motivated and self-starter. **Additional… 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
- 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