- Sanofi Group (Morristown, NJ)
- …assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers ... asset and indication strategy meeting, as well as in FDA meetings on invitation. + The Senior COA Lead...COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation… more
- Integra LifeSciences (Plainsboro, NJ)
- …new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & ... new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design &… more
- Bristol Myers Squibb (Princeton, NJ)
- …or CRO settings. + Direct experience managing regulated bioanalytical operations and assay transfer/ validation with CROs. + Practical knowledge of FDA QMSR, GLP, ... and CDx studies, including CRO oversight, assay transfer and validation , sample/data logistics, and discrepancy reconciliation to ensure timely, compliant… more
- Integra LifeSciences (Plainsboro, NJ)
- …design oversight of cost estimating, scheduling, project management, construction administration, validation , with the goal of optimizing Asset Life Cycle Management ... shooting, repairs, and restorations. + Partners with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored… more
- AbbVie (Jersey City, NJ)
- …of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of ... Able to critically review SDTM conformance mapping specifications. + CDISC Validation Tools - Demonstrates extensive knowledge of SDTM, ADaM and define.xml… 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
- System One (Cranbury, NJ)
- …& Equipment Compliance + Ensure facility and equipment maintenance aligns with cGMP, FDA , and other regulatory standards. + Participate in audits and inspections and ... operations, production and manufacturing. + Collaborate with Engineering and Validation teams for equipment installation, qualification, and improvement projects. +… 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
- embecta (Parsippany, NJ)
- …management, verification/ validation , and product release. + Extensive knowledge of FDA and international regulations. + Expertise in ISO 13485, and ISO 14971, ... or design assurance within the medical device, pharmaceutical, biologics, or related FDA regulated industry. + 5+ years in a leadership role with demonstrated… 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