- ICON Clinical Research (Raleigh, NC)
- …to clinical trials + Familiar with regulations and guidance governing clinical trials and drug development (eg ICH, FDA, GDPR, EMA covering GCP, GDP). + Audit ... on our mission to shape the future of clinical development . We are currently seeking a Principal Auditor Quality...for Imaging & Cardiac related external client relationships. + Development of the IMC annual internal audit schedule as… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …the critical clinical procedures on the different clinical studies + Interact with Drug Development department to provide guidance and consultancy to resolve ... than 110 countries and regions. **Primary Responsibilities:** + **Participate in the development and review of the Clinical SOPs, Regulatory documents and Study… more
- Two95 International Inc. (Durham, NC)
- …Rate: $Open/hr. Requirements General Responsibilities: + Plan and conduct analytical tests for drug development and transfer the methods to CDMO + Analyze and ... 10-12+ years of pharma industry analytical experience working within analytical development /validation to support solid oral dosage forms (small molecules), Ph.D.… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** **Director, QA Drug Substance Operations** Are you a strategic leader with expertise in managing teams of QA professionals and collaborating ... to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and… more
- Amgen (Holly Springs, NC)
- …while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will ... The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. ... + Contribute to the preparation for operational readiness related to bulk drug product manufacturing + Possible assignments include: Supporting projects related to… more
- Amgen (Holly Springs, NC)
- …us and transform the lives of patients while transforming your career. Sr. Engineer Drug Substance Facility Projects **What you will do** Let's do this. Let's change ... is in the Process System Engineering team with initial emphasis on drug substance capital project support, subsequent responsibilities may include technical network… more
- Actalent (Durham, NC)
- …player capabilities. + Thorough understanding of regulated clinical trial environments and drug development processes. + Proficiency in using systems and ... Create and review technical and administrative documentation to support business development and enable study initiation and maintenance. + Provide specialist… more
- ThermoFisher Scientific (Raleigh, NC)
- …leading global contract research organization (CRO). We provide comprehensive, integrated drug development , laboratory, and lifecycle management services. Our ... standards. + Manage a small team of Analysts; provide training and development opportunities, evaluate performance of audit team members. + Identify opportunities… more
- ThermoFisher Scientific (Greenville, NC)
- …experience, must have worked within a GCP environment** + Solid knowledge of drug development and clinical trial processes, including related standards and ... daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance. + Ensure high-quality deliverables for… more