- Teleflex (Morrisville, NC)
- …controls for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a ... and service providers * Own the process to deploy system changes through sandbox, development, QA and production environments....* Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …required to be an active contributor to failure root cause analysis, equipment / system / process improvement, and take an active leadership role in the continuous ... improvement of departmental systems and infrastructure. Candidate will also be required to...improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and… more
- J&J Family of Companies (Wilson, NC)
- …support, laboratory equipment lifecycle management including Analytical Instrument Qualification (AIQ) and Computer System Validation (CSV), among others. + ... + Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of… more
- ThermoFisher Scientific (Greenville, NC)
- …particularly 21 CFR Part 11 and EU Annex 11, within laboratory and manufacturing systems . This position is essential for maintaining a culture of compliance with ... FDA , EMA, and other global health authority expectations related...dashboards submitted to global QA. + Assist in tracking system remediation activities for equipment and instruments to ensure… 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
- BioFire Diagnostics, LLC. (Durham, NC)
- …equipment + Troubleshoot and repair complex mechanical, electrical, and automated systems independently + Contribute to root-cause analysis efforts to prevent ... equipment reliability and efficiency + Ensure all maintenance activities comply with FDA regulations, GMP, ISO standards, and safety protocols + Utilize and maintain… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …Summary: This position provides direct support for all USP Water Systems and Autoclaves at bioMerieux, Inc.'s Durham Manufacturing Facility. Responsibilities include ... cause analysis and actively contributing to the continuous improvement of departmental systems and infrastructure. Team members are expected to contribute to 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
- Herbalife (Winston Salem, NC)
- …and distributes records on a timely basis using company software systems and procedures. + Interact with multiple departments including Engineering, Finance, ... Manufacturing, Planning, Product Development, QC, Safety, Sanitation, Sourcing, Training and Validation as it relates to Facilities and Engineering operation at the… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state + Perform computer applications Perform ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more