- United Therapeutics (Durham, NC)
- …continuing education based on findings from oversight activities + Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA audits ... clinical team in preparing for external audits + Facilitate GXP Compliance/QA audit activities for clinical development to include...Degree (scientific related field preferred) + For Clinical Oversight Lead II level: + 8+ years of experience in… more
- ManpowerGroup (Raleigh, NC)
- …Technicians complete calibrations, qualifications, and PMs with accurate and timely GxP documentation, following PCI and/or client specific policies and procedures. ... supervision, completes calibrations, qualifications, and PMs with accurate and timely GxP documentation, following PCI or client specific policies and procedures,… more
- Catalent Pharma Solutions (Morrisville, NC)
- …Business/System Analyst **City:** Morrisville **State** : NC **JOB DESCRIPTION** : + Lead Oracle JDE 9.1 Distribution Supply Chain process with expert level module ... Work on Track-wise Quality Tracking System, quality adherence and GxP guidelines and regulations + Perform all of the...multiple trading partners, Identification of the source and target systems & mapping of the precise data fields; JDE… more
- Amgen (Holly Springs, NC)
- …solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity ... will work hand in hand with the capital project team to deliver robust automation systems to operate the new plant utility and building automation systems . This… more
- CBRE (Research Triangle Park, NC)
- …geographies. **About the role** As a CBRE Regional Ops Director, you will lead the team responsible for running the performance of MEP (mechanical, electrical, and ... plumbing systems ) and maintaining continuity throughout to provide overall quality...performance indicators and financial performance of a region of GxP manufacturing sites. Implement measures to keep performance meeting… more
- Allucent (Cary, NC)
- …management documents as requested to ensure integrity of study data + Lead simple to moderate projects by fulfilling the following responsibilities: communicate with ... study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate...years of relevant work experience + Good knowledge of GxP + Familiarity with relevant regulations and guidelines +… more
- Amgen (Holly Springs, NC)
- …solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity ... hand in hand with the capital project team to deliver robust automation systems to operate the new plant. This includes sophisticated and complicated system… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …the business. IT Quality Engineers support Validation of regulated systems implementations, audits, and inspections. **Specific Responsibilities and Skills** ... .Oversee multiple complex portfolio of systems and ensures validation activities adhere to quality standards and best practices. .Manage an area of the overall IT… more
- Cambrex High Point (Durham, NC)
- …early-stage drug development is highly preferred, including an understanding of GxP . This position supports the achievement of site operational objectives, drives ... be hybrid- required to work in office 2 days per week. Responsibilities + Lead assigned project managers to ensure development of the PM activities and proper… more
- Charles River Laboratories (Durham, NC)
- …for the management, maintenance and operation of the facility and building systems in compliance with AAALAC accreditation, client and executive management criteria ... **Manager Facilities** : + Oversee management, maintenance and operation of site systems to include the physical plant, laboratory, scientific and support equipment.… more