- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and ... compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted… more
- UNC Health Care (Rocky Mount, NC)
- …activities in support of departmental operations. Must meet current MQSA ( FDA ) regulations for a practicing mammographer. Responsibilities: 1. Produces routine ... mammograms, diagnostic mammograms, include, but not limited to: Obtains history and/or examination data and evaluates for contraindicating conditions; Reviews Radiologist's report; Applies shielding, supportive and immobilization devices; Adjusts and controls… 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. **Qualifications:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Excellent interpersonal, influencing and team building skills + Understanding guidelines ( FDA , ICH, EMA and GCP) + Working knowledge of biostatistics, data ... management, and clinical operations procedures + Ability to act as a mentor/trainer to other staff **Physical Requirements / Work Environment:** + Work is performed in an office environment with exposure to electrical office equipment + Occasional drives to… more
- Fujifilm (Holly Springs, NC)
- …Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility **Preferred Requirements** * 2+ years of experience in ... GMP Quality Assurance and/or similar role * Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Working & Physical Conditions** Ability to discern audible cues. Ability to stand for prolonged… 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 ... function. PICC insertion experience using real time ultrasound and PICC tip location system. Ability to be cross trained to insert midline catheters in both Adults and Pediatric population. Ability to be cross trained to insert PICCs in Pediatric population.… more
- Lilly (Concord, NC)
- …manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM degree or certification ... + Highly automated equipment (inspection, packaging, filling, assembly, etc) + Manufacturing Execution Systems and SAP or other electronic business systems + Root cause analysis and implementing corrective actions. + Facility, Equipment, Systems, Start-up… more
- Fujifilm (Raleigh, NC)
- …I. + 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: + 9-15 years… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …and/or Med device or other device-related experience + Demonstrated expertise in applying FDA design control requirements (21 CFR ) as applied to medical device ... software and medical device regulation (IEC-62304) **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking &… more
- ThermoFisher Scientific (Wilmington, NC)
- …Clinical monitoring or clinical site support; and Regulations such as ICH/GCP, FDA guidelines, and local regulations. Four (4) years of experience with: Working ... with project budget and adjusting re-sources accordingly. Three (3) years of experience with: Global experience in managing clinical trials and study teams across regions. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate… more