- Mentor Technical Group (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 ... + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/Systems. + Acts as… more
- Lilly (Durham, NC)
- …deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, etc. + **Technical Excellence:** ... + Understanding of basic requirements of regulatory agencies such as the FDA , DEKRA, and OSHA. + Excellent interpersonal, written, and oral communication skills… more
- Cambrex High Point (High Point, NC)
- …conducts data review activities for data generated by GMP Analytical for validation of analytical test methods, testing of cleaning samples, raw materials, process ... Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines. Qualifications/Skills Fundamental understanding (experience is not… more
- Merck (Durham, NC)
- …+ Completes in-process testing and inspections supporting the vaccine manufacturing, validation , and development processes as required. + Identifies and addresses ... Experience and Skills:** + BioWorks Certificate (working in an FDA regulated industry). \#MSJR Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)… 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 ... + Excellent interpersonal, influencing and team building skills + Understanding guidelines ( FDA , ICH, EMA and GCP) + Working knowledge of biostatistics, data… more
- J&J Family of Companies (Wilson, NC)
- …team professionals with various technical expertise, responsible for the implementation, validation , qualification and maintenance of the ISA-95 level 1 and 2 ... in compliance with all company, state and federal regulations and guidelines including FDA , EPA, OSHA, DEA and TSA. + Ensures regulatory and job training remains… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …proceed with proper decision making + Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- Sodexo (Greensboro, NC)
- …and clinical settings. This role will be responsible for maintenance, repair, and validation of sterilizers and related systems at client sites. We're looking for a ... + Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed service documentation and logs for compliance and… more
- Sodexo (Greensboro, NC)
- …and clinical settings. This role will be responsible for maintenance, repair, and validation of sterilizers and related systems at client sites. We're looking for a ... + Calibrate and validate sterilizers in compliance with manufacturer, AAMI, and FDA standards + Maintain detailed service documentation and logs for compliance 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