- Kerry (Clark, NJ)
- …but not limited to Golden 6, Hygienic Zoning, etc. Ensure all cleaning validation and verification activities are consistent with Kerry policies and procedures and ... detection systems to ensure they are in top performance Enforce SQF, USDA, FDA , and Kerry standards. Ensure communication is met between third-party service provides… more
- Sanofi Group (Bridgewater, NJ)
- …development activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical ... part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health… more
- Integra LifeSciences (Princeton, NJ)
- …to lead successful teams. An understanding medical device sterilization processes, validation , and control is preferred. The qualified candidate must understand the ... industry standards such as ISO 13485, ISO 11135, ISO 11137, and FDA requirements. **Cross-Functional Collaboration:** + Work closely with R&D, manufacturing, quality… more
- Integra LifeSciences (Plainsboro, NJ)
- …testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is ... Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive.… more
- Mentor Technical Group (NJ)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... + Strong project management background within, for example, production, engineering, validation or quality; with a solid understanding of manufactured dosage forms… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. + Develops and optimizes new ... testing of products. Develops stability indicating methods and performs methods validation . + Provides timely responses to all internal and external inquiries.… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... audits performed by clients and health authorities, in the scope of the Qualification and Validation area - Carry out assigned tasks and duties in a safe manner, in… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required. ... required. + Conducts internal audits for compliance with SOP, cGMP & FDA requirements. Additional Responsibilities: + Initiates, investigates and completes CAPA for… more