- 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
- Sumitomo Pharma (Trenton, NJ)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… 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
- Bristol Myers Squibb (Summit, NJ)
- …+ Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + Advanced ... to effectively manage multiple tasks and activities simultaneously. + Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and… 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
- Insight Global (Edison, NJ)
- …support) SDLC/ITIL (incident/priority/resolution) - Familiar with GxP systems, Computer System Validation and in the support of FDA regulated systems and ... business (knowing you cant plug and play just understanding) - 2-3 days on-site Warsaw, IN/Raynham, MA (prefer MA) Experience in application development and support preferred. Training with certification (Green or Black Belt) in Process and/or Design… more
- Sumitomo Pharma (Trenton, NJ)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… 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 standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED… more