- Sutter Health (San Francisco, CA)
- …Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). Ability to perform basic pharmacy ... buyer duties. Possess written and verbal communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. Well-developed time management and organizational skills, including the ability to… more
- Actalent (Los Angeles, CA)
- …ensures compliance with ICH-GCP (E6 R2/R3), applicable regulatory requirements (such as FDA , EMA, Health Canada, MHRA), and the sponsor's Quality Management System ... (QMS). This position focuses on evaluating the quality, consistency, and adequacy of site monitoring, issue management, and documentation practices to ensure trial integrity, subject safety, and data reliability. Responsibilities + Provide continuous oversight… more
- Medtronic (Northridge, CA)
- …Quality management, CAPA, Complaints handling. + Ensure regulatory readiness and support FDA audits by maintaining validated system states (ISO 13485, HIPAA, GDPR ... compliance) into all deployments and across all IT services. + Partner closely with our Director of IT, Manufacturing and Director of Business Systems to achieve system integrations across enterprise platforms, such as linking QMS/PLM with ERP (eg, SAP),… more
- Astrix Technology (Camarillo, CA)
- …with **environmental monitoring, swabbing, endotoxin, and bioburden testing** + Knowledge of ** FDA cGMPs (21 CFR 211)** ; cleanroom experience preferred + Proficient ... in **Microsoft Excel** **INDBH #LI-DNP** We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or… more
- ThermoFisher Scientific (Santa Clara, CA)
- …* Demonstrated expertise in safety management and regulatory compliance (GMP, FDA , EH&S) * Proven experience implementing Lean manufacturing and process improvement ... methodologies * Excellence in financial and business performance management * Strong leadership abilities with experience developing and mentoring teams * Strong analytical and data-driven decision-making capabilities * Excellent communication and… more
- Merck (Sacramento, CA)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Medtronic (San Diego, CA)
- …ongoing utilization of our solution-based software technology as cleared by the US FDA , as appropriately regulated + Possess and deliver a thorough understanding of ... healthcare economics specific to the customer and deliver targeted messaging to validate the value proposition of Medtronic AI platforms + Initiate and lead engagements with internal cross-functional leaders to accelerate and close the sales process. +… more
- Actalent (Thousand Oaks, CA)
- …activities with specific regard to protocol timelines. + Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. ... + Maintain effective relationships with study participants and other research personnel. + Interact in a positive, professional manner with patients, sponsor representatives, and investigators. + Coordinate and attend pre-study site visits, site initiation… more
- Actalent (Irvine, CA)
- …+ Experience with non-conformances, investigations, and CAPA's. + Knowledge of FDA regulations and risk mitigation strategies. + Proficiency in NCMR, product ... discrepancies, and change control. + Strong technical writing skills. Additional Skills & Qualifications + Bachelor's degree with 2 or more years of experience in a relevant field. Work Environment The work environment is on-site in a manufacturing setting… more
- Sutter Health (Modesto, CA)
- …Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written and verbal ... communications skills to explain sensitive information clearly and professionally to diverse audiences, including non-medical people. + Well-developed time management and organizational skills, including the ability to prioritize assignments and work within… more