- Abbott (Pomona, CA)
- …(CAPA) activities, equipment maintenance, product and process planning, quality audits, validation . + Aid in implementing process improvements with respect to ... required. + Assist with equipment, process and facility qualification and validation activities as required. + Responsible for exhibiting professional behavior with… more
- Kelly Services (Irvine, CA)
- …product drawings and documents. + Establish and perform verification and validation activities including design verification testing, process and packaging ... validation and shelf-life studies. + Prepare product and process...and technical development. + Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up… more
- Gilead Sciences, Inc. (Foster City, CA)
- …collaborations with other CMC functions. + Working knowledge of lab automation, computer validation , data governance, data science, knowledge management and data ... HPLC-CAD, _etc_ .). Author associated method development reports, test procedures, validation protocols and reports. + Proactively evaluate and implement state of… more
- Genentech (Oceanside, CA)
- …+ Support virtualization (VMware) and system redundancy for critical GMP applications. **Compliance & Validation ** + Ensure systems meet GxP and FDA 21 CFR Part ... automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The… more
- Sutter Health (Palo Alto, CA)
- …policies and department standards. + Completes all annual competency validation requirements. + Participates in quality improvement processes, including updating ... Drug Enforcement Administration (DEA), and the Food and Drug Administration ( FDA ) by monitoring nursing unit inspections; maintaining records for controlled… more
- GRAIL (Menlo Park, CA)
- …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
- Sumitomo Pharma (Sacramento, CA)
- …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 (Sacramento, CA)
- …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
- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... + Ability to make independent decisions + Knowledge of validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP + Basic proficiency in SolidWorks… more
- Abbott (Alameda, CA)
- …of automation solutions. **Data Integrity, Governance & Analytics:** + Implement data validation and monitoring processes to ensure data integrity across systems. + ... and support continuous improvement initiatives. + Implement robust data validation processes to support reliable decision-making. + Utilize data analytics… more