- Abbott (San Diego, CA)
- …the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA , and other regulatory agencies + Understands and is aware of the ... their area of responsibility, including product design, verification and validation , manufacturing and testing activities + Responsible for exhibiting professional… more
- Abbott (Sylmar, CA)
- …*Evaluation of production equipment. *Process characterization and process validation . *Interface with vendors for incoming components. *Troubleshoot manufacturing ... regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards. Contribute expertise to ... associated with QbD, comparability evaluation, scale up, and method and process validation . The salary range for this position is: Other US Locations: $274,550.00… more
- Bayer (Berkeley, CA)
- …Ensures conformance to all regulatory requirements, including those of the FDA and various international regulatory governmental bodies; + Interpret those regulatory ... regulatory agencies, where applicable, and responses to regulatory comments, and validation protocols and reports; + Responsible for evaluating new technologies and… more
- Sumitomo Pharma (Sacramento, CA)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Imperative Care (Campbell, CA)
- …requirements. + Lead design-focused risk analysis activities, product verification and validation test planning, and oversee product test development and execution. ... Experience working under quality systems designed to meet governmental regulations such as FDA , GMPs, QSR, ISO 13485/9001, and the MDD. + Experience leading a… more
- Sumitomo Pharma (Sacramento, CA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- J&J Family of Companies (Santa Clara, CA)
- …8+ years' work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer ... and improve usability. + Proven knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering. + Solid understanding of ISO 14971 and IEC… more
- ZOLL Medical Corporation (San Jose, CA)
- …the products. + Drive the development, documentation, prototyping, testing, validation and implementation of new/improved manufacturing processes. + Perform various ... involving electromechanical and/or catheter-based products (preferred). + Lean methodologies, FDA , ISO. Knowledge, Skills and Abilities + Solid background in… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …implementation of BD initiatives, including but not limited to Lean, Six Sigma, Validation , and SAP ERP business processes while ensuring alignment to business and ... innovative, and willing to take calculated risks. + Knowledge of GMP, ISO and FDA regulations specific to the life sciences industry. + Knowledge of MRP/ ERP Systems… more