- J&J Family of Companies (Santa Clara, CA)
- …or 6 years of experience with a Master's Degree. + Knowledge 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. +… more
- J&J Family of Companies (Santa Clara, CA)
- …+ 3-5 years of experience in a medical device environment. + 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… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …work environment by adhering to safety guidelines and policies and enforcing compliance with California state, regulatory, and federal EPA regulations + Oversee the ... of related experience. Experience in the pharmaceutical, biotechnology or other FDA -regulated industry strongly preferred + Minimum 5 years' experience in… more
- Sutter Health (Oakland, CA)
- …*Protects patients and technicians by adhering to infection-control protocols. COMPLIANCE . *Maintains strictest confidence of all patient protected health ... Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ), and United States Pharmacopeia (USP). Possess written and verbal… more
- BioLife Plasma Services (Sacramento, CA)
- …develop the skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:** Through our ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Abbott (Alameda, CA)
- …clinical research or related field. + Education and work experience in research compliance , or quality, project management, or life sciences or clinical research. + ... best practices for clinical trials familiarity with regulatory frameworks (eg, FDA , EMA, ICH-GCP). + Knowledge of global clinical research operations. **Preferred… more
- Cordis (Irvine, CA)
- …about off-label products or indications + Collaborate with regulatory and compliance teams to ensure all scientific/marketing materials adhere to relevant ... regulations and standards (eg, FDA , CA, PMDA,Sunshine Act) + Responsible for identifying clinical insights and knowledge gaps and be able to articulate the impact… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV.… more
- ManpowerGroup (San Diego, CA)
- …+ Collaborate across functions including V&V and QA. + Ensure compliance with internal standards and regulatory requirements. **Qualifications:** + Bachelor's degree ... **Preferred:** + Experience with medical device regulations (ISO 13485, IEC 62304, FDA 21 CFR Part 820). + Familiarity with cloud testing and post-market… more
- Abbott (Pleasanton, CA)
- …including integration and end-to-end testing, to support overall product quality. + Compliance & Quality Assurance: Ensure all test strategies and practices align ... with medical device regulatory standards ( FDA , ISO, IEC 62304).Support documentation, verification, and validation processes required for regulatory submissions and… more