- Gilead Sciences, Inc. (Foster City, CA)
- …resource, budget and program milestones. + Working knowledge of lab automation, computer validation , data governance, data science, knowledge management and data ... in high throughput assay methodologies, including automation + Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning… more
- Medtronic (San Diego, CA)
- …with technology developments in specialized area + Experience working in an FDA -regulated and/or medical device environment with ISO and Quality System Regulation ... methodologies including requirements development, analysis, allocation, review, tracing, and verification/ validation + Knowledge of manufacturing processes including machining and… more
- Abbott (Alameda, CA)
- …"audit ready" at all times (project team training records, central files, system validation , etc.). + If applicable, ensure adequate monitoring is conducted on all ... and regulatory compliance guidelines for clinical trials (eg applicable ISO Standards, FDA ). + Strong problem-solving skills. + Advanced knowledge of clinical and… more
- Terumo Neuro (Aliso Viejo, CA)
- …Develop test plans, protocols, and reports as part of design verification and validation . + Develop designs that are robust and optimized for manufacturability. + ... and organized design history, detailed 2D drawings and BOMs. 6. Proficient computer skills, including MS Word, Excel, Outlook, and Teams. **Desired Qualifications**… more
- Actalent (Irvine, CA)
- …+ Assist in the development and review of process and equipment validation /qualification. + Execute quality activities related to manufacturing transfers to other ... Ability to work independently and as part of cross-functional teams. + Computer literacy. Additional Skills & Qualifications + Previous industry experience desired.… more
- Medtronic (Irvine, CA)
- …activities, and resolution of assembly issues. + Ensure full compliance with FDA regulations and applicable international standards throughout all phases of process ... and process FMECA (Failure Modes, Effects, and Criticality Analysis), process validation , and process control strategies. + Familiarity with Design for… 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 ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
- Stryker (San Francisco, CA)
- …then applied at build and configuration, provide oversight through verification and validation . Once the product is on-market, this team also aids others with ... taskforce teams. **Knowledge and Capabilities:** + Understanding of the current revisions from FDA , NIST, ISO, IEC on the related security topics. + Expertise in… more
- Element Materials Technology (Santa Fe Springs, CA)
- …and regulatory training and development of colleagues (including cGMP training including FDA and ICH guidelines) + Participate and advise on adjustments to quality ... other cGMP documentation + Ensure proper Review and approval of validation , qualification, protocols and reports + Ensuring that quality-related investigations are… more
- Rise Baking Company (Irvine, CA)
- …using established laboratory/pilot plant/operations methods, ensuring all experiments meet FDA food manufacturing guidelines; keep accurate and detailed records on ... solutions + Execute pilot lab runs, consumer tests, plant trials, and validation trials + Lead small and medium projects, demonstrating good teamwork, effectively… more
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