- Mentor Technical Group (South San Francisco, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Hologic (San Diego, CA)
- …documentation, including development and notebook studies for operations. + Participates in FDA , ISO lab audits and performs BSL3 audits. + May represent group ... as extended core team member on one or more core teams or on other teams. + Interfaces with R&D to learn new process and transfers knowledge to department. Reviews and approves process transfer reports, as required. + Performs feasibility studies and assists… more
- Kelly Services (Lodi, CA)
- …Skills:** + Familiarity with ISO standards and regulatory requirements (CE/ FDA /QSR, GDP). + Strong documentation and record-keeping skills. + **Qualifications ... & Skills:** + Education: High school diploma or equivalent required. + Experience: Minimum of 2 years in a manufacturing or regulated environment. + Must be comfortable working in an environment where you have to wear PPE at all times + **Soft Skills:** +… more
- Insight Global (San Diego, CA)
- …of IT experience working in a pharmaceutical company with exposure to FDA regulations. * Experience supporting validation applications for regulatory purposes in a ... biotech/pharmaceutical company * Technical experience and knowledge of Microsoft applications utilizing the following technologies: MS SQL Server, Oracle, JAVA, Visual Basic, MS Access, MS Project, IIS, Internet Explorer, and * Experience with Advanced Web… more
- Abbott (Pleasanton, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. **EDUCATION AND EXPERIENCE YOU'LL BRING** **Required** + Minimal four-year BS degree in an engineering… more
- Abbott (Santa Clara, CA)
- …programs, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption ... (Foreign Corrupt Practices Act); + Representing Abbott externally to suppliers and customers; and + Helping select and/or directing the work of outside counsel, defining project objectives, managing project, and monitoring outside counsel budget. **Critical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …changing priorities + Complete knowledge of Food & Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable national regulations, ... International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools. + Familiar with… 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 ... designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs + Enhance intellectual property position of the company via invention disclosures and patent… more
- Hologic (San Diego, CA)
- …and scientific problem-solving. + Experience with complaint investigation, CAPA, and quality systems ( FDA , ISO 13485, EU MDR). + Understanding of 21 CFR, ISO 13485, ... ISO 14971 and other regulations relevant to Molecular Diagnostic Industry is desired. + Experience with manufacturing and design of IVD products is desired. + Technical Skills: + Technical expertise with a strong emphasis on leading projects and investigations… more
- Cedars-Sinai (Los Angeles, CA)
- …provides extensive patient education, reviews and prepares charts for clinic, follows FDA guidelines for third party donors, and supervises other nursing staff. + ... Coordinates clinic on the weekends and holidays, ensures outside lab kits are available, refills medications and submits for prior authorization if needed. Acts as the super trainer for Point of Care urine and glucometer and performs NST testing in the… more