- Providence (Napa, CA)
- **Description** The Regulatory Readiness Specialist supports the ministry through the management and improvement of system-wide processes related to ... organizational surveys and regulatory readiness activities. The Regulatory Readiness Specialist assumes responsibility for all aspects of site… more
- Bayer (Berkeley, CA)
- …and diverse minds to make a real difference, there's only one choice.** **Production Specialist II Cell Therapy Drug Product** **Production Specialist II - Cell ... Therapy Cell Culture- Berkeley, CA** **PURPOSE** This Production Specialist III is responsible for clinical manufacturing novel cell therapy drug substance within… more
- BeiGene (Emeryville, CA)
- …Responsible for managing all TMF operations and is accountable for TMF quality , inspection readiness , and compliance. Provides Trial Master File (TMF) ... conducted in accordance with Standard Operating Procedures (SOPs), policies, GCP, applicable regulatory requirements, and meets quality and timeline metrics. +… more
- Sutter Health (Livermore, CA)
- …areas of the Laboratory. Plays a key role in maintaining accreditation readiness ; participates in accreditation surveys and regulatory agency inspections. ... in one or more areas of the laboratory. Duties routinely include evaluating Quality Control (QC) and Proficiency Testing (PT), taking corrective action when needed,… more