- Sumitomo Pharma (Raleigh, NC)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- GRAIL (Raleigh, NC)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... work with other maintenance and technical trades, contractors, engineers, metrology, validation , and quality to help keep these systems operational while adhering… more
- Herbalife (Winston Salem, NC)
- …process capability trials in support of commercial deployment of systems. + Support validation /qualification line work, including FAT, SAT, IQ, OQ & PQ, at HWS ... of GMPs and other regulatory requirements. + Proficient with computer software including MS Outlook, Word, Excel, Adobe. +...a plus. + Exposure to HACCP/AIB, CFR 21 and/or FDA food regulation guidelines is a plus, + Electrical… more
- Sumitomo Pharma (Raleigh, NC)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more
- ThermoFisher Scientific (Morrisville, NC)
- …(primary and secondary) + QC laboratories (Analytical and Microbiological) + IT / Computer systems validation + Clinical and commercial stage products and ... experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA , EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections. **Knowledge, Skills,… more
- Herbalife (Winston Salem, NC)
- …Manufacturing, Planning, Product Development, QC, Safety, Sanitation, Sourcing, Training and Validation as it relates to Facilities and Engineering operation at the ... collaborative working relationship with internal customers, and contract vendors.* Proficient with computer applications * Must have a valid Driver's License with a… more