- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** + Coordinates data ... May train clinical research staff to help improve the quality of the data being collected. + May solve...verbal communication skills. + Ability to strictly adhere to regulatory requirements and ethical guidelines. This role is designed… more
- ThermoFisher Scientific (San Francisco, CA)
- …operations (scheduling, execution, NPI) are controlled and performed within cGMP regulatory guidelines and Thermo Fisher Scientific global quality standards. ... in operations. The foundation of everything we do is anchored in safety and quality integrated within a continuous improvement approach. **A Day in the Life:** +… more
- Globus Medical, Inc. (San Diego, CA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Partnering with ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …with software development lifecycle (SDLC) and validation tools. + Knowledge of GAMP 5, FDA 21 CFR Part 11, and other regulatory frameworks. + A strong ... ability to work collaboratively with interfaces to Process Engineering, Quality , Project Managers, Facilities, Automation, and other groups. +...At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Monitoring progress against schedule Communicating to all stakeholders (engineering, quality , regulatory , manufacturing, supply chain, marketing) Closure of ... be responsible for managing Sustaining Engineering projects in accordance with FDA regulations and company standards. The Project Manager's primary duties include… more
- ThermoFisher Scientific (Fremont, CA)
- …or distribution + Familiarity with handling hazardous chemicals and adhering to quality and regulatory standards **Knowledge, Skills, Abilities** + Knowledge of ... Supervise a team of 4-5 to achieve delivery, safety, quality , and cost targets + Support operational goals and...manufacturing techniques, FDA , GMP, and ISO 13485 compliance + Proven ability… more
- Abbott (Alameda, CA)
- …Managers and other Subject Matter Experts from IT, R&D, Commercial, Clinical, Regulatory , Quality , Manufacturing, and other functions. + Confirms the ongoing ... responsible for project leadership of IT programs that support business critical quality systems. Projects may include + Replacement of Product Lifecycle Management… more
- ThermoFisher Scientific (Fremont, CA)
- …knowledge of laboratory and potentially hazardous chemicals. + Advanced understanding of quality standards and regulatory compliance for medical devices or ... good manufacturing practices (cGMP) with the highest level of quality and compliance in a safe and timely manner...diagnostics. + Strong technical skills in FDA , GMP, ISO 13485 compliance, process improvement, and development.… more
- Antech Diagnostics (Fountain Valley, CA)
- …+ Experience in regulated industries (finance, healthcare, manufacturing, etc.) applying regulatory regulations and/or security frameworks under a quality ... Our culture is centered on our guiding philosophy, The Five Principles: Quality , Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the… more
- VTI Life Sciences (Los Angeles, CA)
- …Plans + Construction Signage + Plant-wide Communications. + Generate and Manage Quality Management Plans and Documentation + Construction Control Plan + Manage ... Documentation + Risk Assessment and Mitigation + Change Control + Quality Audits Validation Support + Equipment Installation Qualification, Operational Qualification… more