- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA , EMA, PMDA) and internal standards. + Support internal audits and ... regulatory inspections, including readiness activities and remediation. + Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement. **Leadership & Collaboration** + Serve as a technical… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …in clinical trials and in routine medical practice, as governed by regulators (eg FDA , IRB , CLIA , HIPAA ). Duties and responsibilities will primarily include, ... but not limited to: + Design, execute, and troubleshoot complex experiments focused on genetic tests of human tissue/liquid specimens. + Data analysis, documentation of clinicogenomic findings. + Lab management (laboratory safety, human subject protections,… more
- Fujifilm (Durham, 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:** Experience: + Zero to two years of experience with Web Development, Web Performance testing tools. + Basic Experience in C#, JavaScript, and PowerShell. + Experience in .NET, Microsoft Team… 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** + Bachelor's degree in computer science, Information Systems, Electrical/Mechanical Engineering, or other related field with a minimum of 8 years technical support related experience or… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston and we serve life sciences clients in six global… more
- Fujifilm (Holly Springs, NC)
- …* Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QCAD ... team to investigate any project challenges with necessary risk assessment tools and techniques, as needed * Supports best practices for TT and PPQ strategies globally, as required * Coordinates and supports QCAD Bioassay lab activities and provide training for… more
- Fujifilm (Holly Springs, NC)
- …driven organization + Experience working in a CGMP facility and with FDA regulations **Preferred Requirements** + Master's degree in engineering or related ... scientific field + 6-10 years' experience in a pharmaceutical / biological manufacturing operation + Previous experience leading an automation team at a greenfield site **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** Will work in environment which may… 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:** Technical professional experienced in designing, implementing, documenting, and executing complex technical projects. A person in this position is expected to possess an expert level… more
- Fujifilm (Durham, 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 Computer Science, Information Technology, or related field + 5 years of experience with TFS/Azure DevOps Server with build and release management + Strong… more