- Reckitt (Wilson, NC)
- …departments, and external resources. + Ensure project scopes fulfill relevant regulatory requirements including compliance with company requirements, FDA ... regulations, and state/federal EHS requirements. + Prepare project budgets and cash flow projections. + Create project implementation timelines ie milestone and detailed project schedules. + Prepare capital appropriation requests and route to obtain management… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …in a timely manner, while maintaining compliance with all company and regulatory agency regulations + Perform technical writing as it relates to Preventive ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- RELX INC (Raleigh, NC)
- …strategy. This role ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives software development best ... and Professional. LexisNexis is a leading global provider of legal, regulatory , business information and analytics that help customers increase productivity, improve… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …turnover package. + Ensure compliance with company, environmental, building code, and regulatory policies and procedures and is responsible for optimum use of staff ... utility systems. + These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Author protocols, reports, and documentation aligned with GMP and regulatory requirements. + Support the integration of process data infrastructure, visualization, ... analysis** , data preprocessing, and validation methods + Familiarity with **GMP** , FDA /EMA guidelines, and ICH standards related to PAT and model validation +… more
- North Carolina State University (Raleigh, NC)
- …team members, coordinating projects, organizing communications and meetings, managing regulatory activities (eg, IRB submissions, modifications, and renewals), and ... study administrative duties and budgetary activities. Required Qualifications: + Experience working on FDA regulated trials + Ability to work with a high degree of… more
- 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 ... additional language skills are a plus. + Strong understanding of regulatory requirements and quality standards. + Excellent analytical, problem-solving, and… more
- Fujifilm (Holly Springs, NC)
- …works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with ... European Medicines Evaluation Agency (EMEA) or Food & Drug Administration ( FDA ) regulations *Proficient in Microsoft Office (eg, Word, Excel, PowerPoint, SharePoint)… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …of goals and help to foster a positive work environment. + Monitor the regulatory environment and recommend changes, as needed. + Ensures all studies performed are ... policies and procedures concerning the conduct of clinical trials, including FDA Good Clinical Practice (GCP), International Council on Harmonization (ICH)… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …lumbar puncture and accessing intrathecal drug delivery devices, study startup, regulatory activities and the management and treatment of metabolic/genetic patients. ... APP will also provide oversight for administration of both investigational and FDA -approved enzyme replacement therapy infusions for patients with lysosomal storage… more