- 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
- Cambrex High Point (Durham, NC)
- …to read and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry and scientific calculations ... + Hands on experience in analytical techniques such as HPLC, GC, etc + Strong computer skills + Ability to operate laboratory equipment and computers + Ability to take direction from experienced scientists and contributes in a team + Environment + Ability to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) OR Three years of warehouse experience in a ... non-regulated industry. Work is performed in a warehouse environment. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling, crawling… more
- Kedplasma (Hickory, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the… more
- System One (Sanford, NC)
- …multiple projects and priorities in a fast-paced environment. + Familiarity with GMP, FDA , or other regulatory standards is a plus. Preferred Experience: + 3+ years ... of experience in CAD drafting, project coordination, and/or project management. + Experience in pharmaceutical, biotech, or industrial engineering environments. + Understanding of capital project workflows, documentation control, and project lifecycle… more
- System One (Raleigh, NC)
- …3+ years of pharmaceutical/biotech working experience in Quality Assurance in an FDA -regulated industry. + Experience with batch record review, document control, and ... release processes. + Familiarity with SAP inventory system. + Proficient in Microsoft Office tools, and Veeva Quality systems. + Strong organization and communication skills and technical writing skills. + Must be self-directed, goal-oriented, and quality… more
- CaroMont Health (Gastonia, NC)
- …by College of American Pathologists, Joint Commission, CLIA, AABB, CMS, and FDA . Responsible for coordinating off site inspections in conjunction with College of ... American Pathologists. Responsible for maintaining CLIA licensure and regulatory accreditation documentation for CRMC-Gastonia, CRMC-Belmont, CMG-Hematology Oncology and Mt. Holly. Responsible for ensuring CLIA licensure and regulatory accreditation… more
- Cardinal Health (Greensboro, NC)
- …and Safety) + Enforce Cardinal Health compliance and regulations for OSHA, DEA, FDA , state and local authorities, primary facility contact for QRA compliance. + ... Evaluate current procedures and practices for accomplishing department objectives **Qualifications** + Bachelor's degree preferred + 7 -10 years of experience in a distribution environment preferred + 5 years of operations management experience preferred +… more
- Cole-Parmer (Raleigh, NC)
- …skills and troubleshooting abilities + Adherence to quality systems with special regard to FDA , ISO 13485 and GMP / OSHA compliance + QC testing of components and ... finished products + Inventory management of materials and supplies + Focus on continual process improvement + Cleaning and maintenance of equipment + Guided experimental design and product testing assigned by supervisor + Preparation of reagents, media, and… more
- Novant Health (Wilmington, NC)
- …in dynamic environments. + Expertise in regulatory compliance (ICH/ FDA /OHRP), clinical trial budgeting/contracting, IRB/IBC relations, and data privacy/security ... (HIPAA). + Strong proficiency in MS Excel, PowerPoint, Word, CTMS, and e-IRB, with experience across diverse therapeutic areas, including oncology, neurology, cardiology, and infectious disease. Job Opening ID 108651 more