- 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 ... time management skills with ability to multi-task without compromising quality + Excellent communication and documentation skills **Preferred Qualifications** +… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …labeling against approved artwork using proofreading skills * Interacts with Quality Operations Incoming Inspection, QO Release, Biochemistry and Packaging to ... Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs) +… more
- IQVIA (Durham, NC)
- …and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity. + Works closely with study leads and Data Management ... + Expert knowledge of SDTM and ADaM data standards and FDA /PMDA/EMA submission requirements required + Therapeutic experience in Oncology, Virology, and/or… more
- Chiesi (Cary, NC)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... professionals + Knowledge and experience in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care… more
- United Therapeutics (Raleigh, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... processes + Ability to lead region in delivery of consistent and quality education to hospitals and healthcare professionals + Ability to strategically develop… 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 ... author and refine SOPs, batch documents, and standard work instructions, setting clear quality and safety standards from day one. You will help recruit, schedule,… 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 ... audit readiness, and long-term scalability + Conduct rigorous testing and quality assurance of automation and integration solutions to ensure reliability,… more
- Fujifilm (Raleigh, NC)
- …the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- HCA Healthcare (Asheville, NC)
- …Experience in trouble shooting central venous catheter occlusions and administering FDA approved fibrinolytic drug to restore central venous catheter to full ... the top 1% of hospitals in the nation for providing the highest clinical quality year over year. Leapfrog Hospital Safety Grade recognized Mission Hospital with an… more
- ThermoFisher Scientific (Greenville, NC)
- …improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures, rationales, and ... methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification. **Keys to… more