- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... health authorities, in the scope of the Qualification and Validation area - Lead functional teams or projects by...audits - Fluency in written and verbal English - Computer literate with good working knowledge of the MS… more
- Sumitomo Pharma (Trenton, NJ)
- …+ 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
- Integra LifeSciences (Plainsboro, NJ)
- …and approve quality documents requiring QA oversight (eg, IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier ... and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the...required + Must possess a team-focused attitude + Demonstrated computer skills. + Ability to work independently. Salary Pay… more
- Zimmer Biomet (Farmingdale, NJ)
- …in department and cross functional meetings as necessary. + Executes validation protocols, gage repeatability and reproducibility (R&R) testing, data analysis and ... makes good judgment in the performance of duties. + Computer literate: Microsoft Word, Excel and Power Point. +...Microsoft Word, Excel and Power Point. + Knowledge in FDA & ISO regulations are a plus. **Your Background**… more