- Gilead Sciences, Inc. (Foster City, CA)
- …through dotted lines and influence decisions at all levels. + Working knowledge of FDA , EMA, and cGMP standards for combination products. The salary range for this ... position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** + BA/BS or equivalent, preferably with… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **Primary Duties and Responsibilities:** + ... Scheduling of research participants for research visits and procedures. + In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) information about changes in research participant condition, adverse… more
- J&J Family of Companies (Santa Clara, CA)
- …of and compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD and other applicable regulations. + Experience and understanding Process ... Validations (IQ, OQ, PQ), 6S, Lean Manufacturing + Experience applying statistics and using statistical software, running Capability Studies (Cpk's), and planning and analyzing DOE's. + Demonstrated proficiency in written and verbal communication, including… more
- University of Southern California (Los Angeles, CA)
- …studies such as National Cancer Institute (NCI), Food and Drug Administration ( FDA ) and pharmaceutical audits. + Completes spreadsheets for industry studies in real ... time to ensure sponsor is invoiced appropriately and timely. + Ensures confidentiality, accuracy, security and appropriate access of all data and records. + Performs other related duties as assigned or requested. The university reserves the right to add or… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **_*This position is hybrid*_** **Primary Duties ... and Responsibilities:** + Scheduling of research participants for research visits and procedures. + In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) information about changes in research… more
- J&J Family of Companies (Santa Clara, CA)
- …security, maintenance, operations, monitoring, and updates. + Experience working in FDA regulated environments is a plus. **Additional Information:** + The ... anticipated base pay range for this position is $105,000 to $169,050 annually. + The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in… more
- Abbott (Pleasanton, CA)
- …groups supported. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. + Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Execute annual goals and objectives as defined by the HF Finance team. **Required Qualifications** +… more
- J&J Family of Companies (Santa Clara, CA)
- …Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA , ISO, MDD, MDR and other applicable regulations. + Understanding of Lean ... and Six Sigma concepts. + Experience with Validation of Medical Devices (IQ-OQ-PQ). + Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE's, Gage R&R) a plus. + Able to create and maintain Drawings in SolidWorks. + Ability to work in a fast-paced… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …of related experience. Experience in the pharmaceutical, biotechnology or other FDA -regulated industry strongly preferred + Minimum 5 years' experience in ... leadership, supervisory or managerial role. **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will… more