- Actalent (East Windsor, NJ)
- …in the laboratory and relevant databases. + Ensure all QC documentation aligns with FDA , ICH, USP, EP, cGMP, and other regulatory guidelines. + Assist in ... + Stay up to date with industry best practices, regulatory changes, and advancements in pharmaceutical quality ...and Dissolution, etc.) and laboratory procedures. + Familiarity with regulatory guidelines such as FDA , ICH, USP,… more
- System One (Fairfield, NJ)
- …within a food, flavor, or dairy manufacturing environment + Familiarity with FDA , GMP, HACCP, and regulatory compliance requirements + Proficiency in ... highest standards of food safety, product integrity, and compliance with regulatory guidelines. This position supports production by validating line setup, auditing… more
- Merck (Rahway, NJ)
- …engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The ... Extensive knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …leadership to project teams. + Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and ... data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs… more
- Sanofi Group (Morristown, NJ)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... efficient prioritization of multiple requests, delegation as needed, and delivering high- quality service to business partners. Confidence working with senior leaders… more
- Actalent (Fair Lawn, NJ)
- …preferably in a regulated industry . Strong understanding of GMP, GDP, and FDA quality system regulations . Demonstrated ability to lead cross-functional ... Quality Process Engineer Overview: The Quality ...ensuring adherence to Good Documentation Practices (GDP) and applicable regulatory requirements (eg, FDA , GMP). . Act… more
- System One (Monroe Township, NJ)
- …compliance with all relevant customs regulations.. Reporting into the Export Regulatory Manager, this role supports our business by managing documentation, tracking ... export compliance requirements, and assisting with audits and regulatory inspections. + Responsible for completing all required export regulatory documentation… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape ... to project teams. + Develop, drive, or support continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and… more
- BeOne Medicines (Pennington, NJ)
- …degree) or 0 years (MS degree) of GMP Pharmaceutical experience working in a quality assurance or manufacturing role in an FDA -regulated company. + Working ... GMP Manufacturing. Works to support QA objectives whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed… more
- Merck (Rahway, NJ)
- …area + Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. This position will… more