- Integra LifeSciences (Plainsboro, NJ)
- …and cycle time reduction to maximize efficiency and productivity. + Process Validation and Documentation: Develop and execute validation protocols (IQ, OQ, ... are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO). Support internal and external audits to maintain compliance and… more
- Integra LifeSciences (Plainsboro, NJ)
- …and cycle time reduction to maximize efficiency and productivity. + Process Validation and Documentation: Develop and execute validation protocols (IQ, OQ, ... are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO). Support internal and external audits to maintain compliance and… more
- Integra LifeSciences (Plainsboro, NJ)
- …updating of standard operating procedures (SOPs) for equipment calibration and validation . + Ensure proper documentation and traceability of calibration activities, ... calibration certificates, where required. + Serve as a project resource to engineering / validation / Quality Control / Microbiology group to assist in the follow up… more
- Actalent (Branchburg, NJ)
- …ability of the product/device to function as intended, including verification and validation of processes. + Assist in the development of processes for manufacturing ... computer systems. + Knowledge of cGMPs, AATB Standards, ISO, FDA , and USP regulatory guidelines. + Experience with SAP...level. The position operates within a cGMPs, GDP, ISO, FDA regulated USP environment. The first shift schedule offers… more
- Merck (Rahway, NJ)
- …+ Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors ... with device design, requirement management, FMEA, design verification, design validation , statistical sampling, and control strategy + Experience with regulatory… more
- BeOne Medicines (Hopewell, NJ)
- …and release of materials, intermediates, and finished products under FDA /EU regulations, applicable International Regulations, BeiGene processes and procedures. As ... years' experience with less than Bachelors. + Experience in an FDA -regulated biotechnology or pharmaceutical company are required with environmental monitoring… more
- Integra LifeSciences (Princeton, NJ)
- …+ Translate SME knowledge to manage the development, implementation, and validation of bacterial endotoxin control programs, ensuring compliance with relevant ... ANSI/AAMI ST72, ISO 11737-3, USP <85>, USP <161>, and FDA guidelines. + Ensure proper integration of endotoxin testing...ANSI/AAMI ST72, ISO 11737-1, USP <85>, USP <161>, and FDA guidelines. TOOLS AND EQUIPMENT USED + Knowledge of… more
- System One (Park Ridge, NJ)
- …+ Drafts eCTD written and tabulated summaries, investigator brochure content, FDA briefing packages, and other agency related technical documents, in collaboration ... microbiological, and packaging methods; method development summaries; method verification, validation , and transfer protocols and reports; standard operating procedures… more
- Vitalief (New Brunswick, NJ)
- …+ Oversee innovation initiatives from concept through deployment, ensuring rigorous validation , scalability, and compliance with clinical standards. + Build, mentor, ... and ensure all AI and software solutions adhere to regulatory requirements (eg, FDA , EMA), industry best practices, and ethical standards. + Implement and enforce… more
- 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