- Charles River Laboratories (Hollister, CA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- Abbott (San Diego, CA)
- …Gain a detailed understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulations, manage project within these requirements. + Gain a ... detailed understanding of overall schedule, manage time and task within schedule. + Runs complex problem solving efforts with some oversight, eg identifies issues resulting in minor downstream impacts; methodically completes test flow to drive conclusions/next… more
- Actalent (Irvine, CA)
- …software. + Medical device industry experience with a deep understanding of FDA regulations, ISO standards, and global quality systems. Additional Skills & ... Qualifications + 10+ years of Project/Program Management experience in the medical device industry preferred. + Demonstrated success managing QA activities in M&A environments, preferred. + Experience coordinating with Regulatory Affairs and Clinical Affairs… more
- Rise Baking Company (Colton, CA)
- …building in a manner that meets and complies with all food safety policies, FDA and OSHA regulations. Essential Functions + Perform basic wash area duties including ... running a pan washer, cleaning utensils by hand when needed, etc. + Perform basic machine disassembly/setup for cleaning (eg, covers, piping, cover electrical with plastic) + Complete cleaning tasks per SSOPs + Recognize and address equipment needing deep… more
- AbbVie (Irvine, CA)
- …+ May coordinate and develop information for reports submitted to the FDA and Global Regulatory Authorities. + May initiate research projects compatible with ... project plan goals and drive them to completion, resulting in high quality publications + Leads cross functional sub-teams overseeing defined sub-projects within the therapeutic area. + Responsible and accountable for the scientific validity, integrity and… more
- Genentech (South San Francisco, CA)
- …The activities would include a systematic review of relevant literature, FDA /BLA/NDA documents, select databases, and/or internal data. + Participate in ... Model-Informed Drug Development (MIDD) by developing and applying mathematical models such as population pharmacokinetics/pharmacodynamics modeling, Physiologically-Based Pharmacokinetic (PBPK) modeling, Quantitative Systems Pharmacology (QSP) modeling, or… more
- Norstella (Sacramento, CA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …Strong knowledge of compliance standards with the Food Drug Administration ( FDA ), international governing entities and Good Manufacturing Practices (GMPs). + ... Excellent oral and written communication skills. + Excellent analytical and proofreading/editing skills. + Strong MS Office and SAP skills. + Ability to operate forklift truck and pallet jack. **Education** Minimum of a high school diploma or GED along with… more
- 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 ... quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing… more
- CliniComp (San Diego, CA)
- …+ Ensure compliance with industry standards and regulations (eg, CLIA, CAP, FDA , HIPAA); + Provide subject matter expertise in LIS configuration, workflow ... optimization, and interoperability with other healthcare systems, diagnostic instruments, reference labs, and downstream systems; + Facilitate the development of internal testing and external training programs to educate client staff on system features and… more