- Lilly (Concord, NC)
- …certification in a related field is a plus + Knowledge of FDA and GMP regulations + Experience operating high-speed, automated production equipment, preferably ... Syringe/Vial Filling systems utilizing Isolator technology + Ability to quickly learn and apply new procedures + Experience working in a classified manufacturing environment + Familiarity with Computerized Maintenance Management Systems (CMMS) platforms +… more
- Fujifilm (Raleigh, NC)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years… more
- Chiesi (Cary, NC)
- …professionals + Knowledge and experience in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care ... practitioner guidelines + Demonstrated proficiency in written, verbal, and face-to-face communications to effectively present information to and influence/support decision-making of managers, working partners, and governmental agencies + Ability to… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings… more
- Univar Solutions (Jamestown, NC)
- …and preparing branch prior to external Compliance and Quality Audits (Customer, Supplier, FDA or other Agencies, and Associations) + Writing SOPs and creating local ... forms for branch + Collaborate with and back up Operations Supervisors + Manage laboratory operations including equipment calibration, sample management, record keeping and the processing of samples with analytical equipment provided to meet branch and… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… 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 ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… 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 ... disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is… 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 ... disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more