- Innovation Foods LLC (Millville, NJ)
- …government requirements. Act as a liaison for regulatory compliance agencies (USDA, FDA , Kosher, Halal, and others) Coach and counsel employees when appropriate in ... relationships and associated microbiology. Must have experience with filing FDA Scheduled Processes and prior experience with process authorities and… more
- Fujifilm (Trenton, NJ)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Taiho Oncology (Princeton, NJ)
- …markets preferred. + Solid experience in quality assurance. + Experience in computer systems and validation requirements. + Working knowledge of TrackWise ... audits, report, CAPA management and close out all audits undertaken. Review/approval of validation documentation as per 21 CFR, Part 11. + Audit of QMS against… more
- System One (Park Ridge, NJ)
- …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
- Cardinal Health (Trenton, NJ)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- 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
- Hormel Foods (Bedminster, NJ)
- …abreast of regulatory changes and ensure R&D operations remain compliant (USDA/ FDA ). + Determine feasibility of project objectives, timelines, and deliverables, and ... set by the strategic business plans. + Ensure shelf-life testing and pathogen validation testing is completed prior to launch and is routinely verified and represent… 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