- 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. **Qualifications** + Bachelor's degree in related technical field or accredited NDT certification, or equivalent NDT work experience within the Oil and Gas industry. + Minimum 5 years' sales and customer… more
- Sysco (Charlotte, NC)
- …years meat and/or seafood industry (as appropriate) experience at a federal CFIA/ FDA meat and/or seafood processing plant (as appropriate). Knowledge of meat, ... poultry and/or seafood products including product specifications. Experience as a Quality Assurance or Quality Control Technician in a meat or seafood processing is desirable. **LANGUAGE SKILLS:** Incumbent must demonstrate ability to write reports, basic… more
- United Therapeutics (Research Triangle Park, NC)
- …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… more
- CSL Plasma (Gastonia, NC)
- …donor disconnect. 2 In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more
- Insight Global (Sanford, NC)
- …Professional Engineer or Certified Project Management certification preferred. Experience with FDA and EU licensing and inspection is beneficial. Familiarity with ... manufacturing and/or utilities equipment and operations is desired. Experience in both Global Engineering and site level engineering is strongly preferred more
- Catalent Pharma Solutions (Greenville, NC)
- …is required + Understanding safety and compliance standards (eg, OSHA, EPA, FDA , and EU regulations) and handling hazardous materials is beneficial + Demonstrated ... ability in project planning, scheduling, resource allocation, and cost estimation preferred + Some exposure to hazardous chemicals and other active chemical ingredients **Why You Should Work at Catalent** + Spearhead exciting and innovative projects +… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment ... Directory, etc). + Manage and maintain labeling documents in document management systems; Manage label review and approval. + Author, contribute, and/or review labeling sections of various periodic reports (ie, Annual Report, PSUR, PADER, etc.). + Support… more
- Vestis Services (Charlotte, NC)
- …Experience, Automation, Material Handling Equipment/Processes, etc. + Knowledge of OSHA, FDA /Food Handling, HAACP, ISO 9000 is preferred + Demonstrated ability to ... execute projects in fast paced and dynamic environments using team-based, data-based approach + Demonstrated ability to coach, teach, and mentor technical and non-technical knowledge to hourly and salaried employees to drive business results + Must have a team… more
- Cytel (Raleigh, NC)
- …maintain relationships with senior stakeholders, including regulatory agencies (eg, FDA , EMA), key opinion leaders, and executive-level client personnel. ... **Scientific & Analytical Leadership** + Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis (NCA), and broader QPP analytical activities. + Provide mentorship, technical oversight, and direction to consultants and analysts,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …or GED + One year of experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is required. + Experience working with cGMPs and Industry Standards ... + Experience in reading, understanding, and following Standard Operating Procedures **KNOWLEDGE, SKILLS, ABILITIES** 1. Possess good verbal and written communication skills 2. Possess basic math skills (addition, subtraction, division, multiplication). 3. To… more