- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more
- IQVIA (Durham, NC)
- …**CONNAISSANCES, COMPETENCES ET APTITUDES REQUISES :** + Connaissance des directives de la FDA (Food and Drug Administration) et de leur impact sur les operations + ... individual contributor role. **REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:** + Knowledge of FDA (Food and Drug Administration) guidelines and their impact on the… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …following standard operating procedures (SOP) and batch records in accordance with FDA current Good Manufacturing practices (cGMP). In addition, personnel in this ... - 5 Years experience in cGMP/Aseptic Operations Background Knowledge & Skills: - FDA /cGMP/GDP - Must possess time management and organizational skills. - Must be… more
- Kelly Services (Winston Salem, NC)
- …support regulatory filings. + Ensure that all documentation aligns with regulatory standards ( FDA , EMA, ICH) and internal SOPs. + Assist in preparing responses to ... process development. + Experience with global regulatory filings and knowledge of FDA , EMA, and ICH guidance. + Exceptional written and verbal communication skills… more
- Owens & Minor (Morrisville, NC)
- …preventive maintenance on vehicles is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery calls as needed and on ... Training Program. + Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES** + Business… more
- US Foods (Lexington, NC)
- …lowest unit cost and manages staff to ensure the integrity, USDA / FDA regulatory compliance, sanitation, shipping receiving and inventory control. **We help YOU ... compliance with internal and external guidelines, including, but not limited to USDA, FDA , OSHA, and Food Safety regulations * Maintains an environment and culture… more
- Fujifilm (Raleigh, NC)
- …when Fuji Dictation software is utilized. + Maintains a clear understanding of FDA requirements and ACR recommendation as well as local state regulations for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development… more
- American Red Cross (NC)
- …and regulatory standards for Cell Therapy Laboratory operations (FACT, FDA , CLIA), drive process standardization, and support workforce development.** **External ... growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards. Develop new theories and solutions, conduct research of emerging… more
- Chiesi (Cary, NC)
- …published by OPDP, and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing Information are reflected in ... regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP + Experience with Veeva Vault PromoMats and MedComms, Trackwise,… more