- Kelly Services (Greenville, NC)
- …eg, pharmaceuticals, manufacturing, etc.]. * Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. * Strong analytical and problem-solving ... skills. * Proficiency in quality management systems (QMS) and relevant software tools. **Preferred Qualifications:** * Certification in Quality Management (eg, Six… more
- ZOLL Medical Corporation (Asheville, NC)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- ThermoFisher Scientific (Greenville, NC)
- …(GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs + Strong organizational skills and flexibility ... of 15-20 lbs. + Ability to access and use a variety of computer software developed both in-house and off-the-shelf. + Ability to communicate information and ideas so… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... such as RAM or Cal Man + Intermediate PC skills and experience with software for tracking and scheduling preventative maintenance events + Strong written and verbal… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... Oracle or SAP as well as Microsoft Excel, PowerPoint and Project software required + Demonstrates flexibility adapting to external environment influences through… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... scientific data, including proficiency with bioinformatics tools and statistical software **Preferred Qualifications** + Master's Degree in biochemistry, chemistry,… more
- ThermoFisher Scientific (Greenville, NC)
- …technical solutions, and make recommendations. + Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. + Proficiency in quality management ... systems (QMS) and relevant software tools. **Qualifications:** Bachelor's Degree required ideally in Chemistry, Biology, or a related physical science with a minimum… more
- Merck (Wilson, NC)
- …setting up process control limits using advanced Excel and/or statistical software packages (Minitab or JMP) + Experience supporting regulatory inspections including ... FDA Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE… more
- Fujifilm (Raleigh, NC)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software * Experience with startup projects or initiatives **Working & Physical… more