- BeOne Medicines (San Mateo, CA)
- …and qc of all navigation and technical acceptance (eg hyperlinking, bookmarking, validation ) to ensure submission compliance for Health Authority (HA) acceptance. + ... of standards, templates, and procedures related to regulatory documents, recommend associated process improvements. + Act as mentor to junior resources. + Assist in… more
- Teledyne (Mountain View, CA)
- …research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an ... for mechanical robustness, and tolerance models + Collaborate with electrical, process , and manufacturing engineering teams to insure seamless integration of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …candidate is expected to serve as the CMC analytical lead on PDM ( Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career ... identify molecule CQAs, design/justify/execute end-to-end control strategies, support CMC process development, issue CoTs, seek Specfication endorsement, and author… more
- J&J Family of Companies (Santa Clara, CA)
- …Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This ... or complexities for programming activities. + Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to… more
- Abbott (Alameda, CA)
- …documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate. + Leads ... sites to bring back understanding on how to resolve quality issues ( process audits). + Evaluates Exception Reports (ERs) issued for nonconforming supplied material… more
- Terumo Neuro (Aliso Viejo, CA)
- …such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans. + Review ... all data management activities to ensure consistency of clinical data process across studies. + Work collaboratively with biostatistics, programming and other… more
- Astellas Pharma (South San Francisco, CA)
- …of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We ... + Interact closely with multiple Astellas teams (Quality Assurance, Quality Control, Process Development, IT, Facilities, etc.). + As assigned, this position may be… more
- Teledyne (Hawthorne, CA)
- …research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research. We are looking for individuals who thrive on making an ... with LabView, python, or similar test and automation software. + Generate validation test plans to ensure products meet specified requirements. + Recommend changes… more
- J&J Family of Companies (Santa Clara, CA)
- …and implement processes, tooling, and fixtures. + Collect data and analyze process performance and capabilities for company products, including new products and ... in-house processing. + Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company...+ Support the transfer of product lines and the qualification- validation efforts. + Other duties as assigned. These job… more
- Medtronic (Santa Ana, CA)
- …standards, geometric dimensioningand tolerancing (GD&T), etc. + Knowledge with PPAP process and part/product validation and qualification. **Physical Job ... to select business teams facilitating design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness.… more