- CSL Plasma (National City, CA)
- …donor disconnect. + In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates ... necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments… more
- Fujifilm (Sacramento, CA)
- …and procedures. + Effective communication within FUJIFILM IVD organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Gilead Sciences, Inc. (Foster City, CA)
- …company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's ... changing priorities + Complete knowledge of Food & Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable national regulations,… more
- J&J Family of Companies (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDD requirements + Prototype and develop proof of concept ... management + Responsible for ensuring proper documentation consistent with company's quality system + Other duties as assigned **Requirements** + Bachelor's degree… more
- Cedars-Sinai (Los Angeles, CA)
- …of caring for patients with reproductive needs and passionate about delivering the highest quality of care and patient satisfaction at one of the best places to work ... provides extensive patient education, reviews and prepares charts for clinic, follows FDA guidelines for third party donors, and supervises other nursing staff. +… more
- AbbVie (South San Francisco, CA)
- …reviewing activities/progress so that projects are delivered on time with suitable quality . Allocates resources to projects such that the correct balance of ... clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including… more
- GRAIL (Menlo Park, CA)
- …management within the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA -regulated environment, with a strong track record of EDC system ... implementation and collaboration with study teams to ensure data quality . + Bachelor's degree required; advanced degree preferred. Additional coursework in… more
- Insight Global (San Diego, CA)
- …management experience (working in a pharmaceutical company with exposure to FDA regulations preferred) * Experience managing technical implementation projects in ... NetSuite) o Familiarity of Veeva and it's support functions including: clinical, quality , safety& regulatory * Experience with ERP * Experience with Microsoft… more
- Terumo Neuro (Aliso Viejo, CA)
- …language, etc.). + Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and ... 21 CFR 820 - Device Labeling, 21 CFR 830 - Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.). 6. Advanced experience with MS Visio… more
- Sutter Health (Castro Valley, CA)
- …in medical and departmental records as required. SAFETY * Participates in quality improvement processes, including updating and revision of safety and procedure ... Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). Possess written and verbal… more