- Eurofins US Network (North Brunswick Township, NJ)
- …and/or AALAS certification at the Technician level is also preferred. Experience in computer system validation and electronic data capture is desirable but is ... Quality Assurance Director as needed during inspections by EPA, FDA or clients. Prepare records and assemble copies of...auditors will have experience in a laboratory regulated by FDA /EPA GLP standards. Experience in other quality standards such… more
- GRAIL (Trenton, NJ)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change… more
- Colgate-Palmolive (Piscataway, NJ)
- …**Responsibilities:** **Product Development & Formulation** + Lead the development and validation of oral care products such as Toothpaste, Mouthrinses and novel ... high-quality commercialization. + Maintain all required documentation under **GMP/GLP** per FDA /ICH guidelines as required. + Documentation may include R&D project… more
- Sumitomo Pharma (Trenton, NJ)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** +...& Technical Skills** + Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related field.… 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
- BeOne Medicines (Pennington, NJ)
- …processes + Strong knowledge of SOX 404 and compliance practices. + Strong knowledge of FDA CFR Part 11 Software Validation processes + Must have experience in ... leading technology functions in Pharmaceutical, Biotechnology or Life Science companies ** Computer Skills:** + Be familiar with MS office 365 applications. +… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …**Programming Oversight & Technical Excellence** + Oversee the design, development, validation , and maintenance of SAS macros, scripts, and applications supporting ... programming infrastructure is robust, scalable, and compliant with regulatory standards (eg, FDA 21 CFR Part 11, GxP), and supports reproducibility and audit… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ Experience with managing a large budget. + Experience in Computer System Validation , Analytical Methods development/transfer, Quality Systems, Product ... regulatory experience in GxP environment. + Previous proven experience dealing with FDA and other major regulatory agencies. + Experience with digital innovation,… 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