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Lab Coordinator

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 03/22/2018 Job Number: JN -032018-21185

Responsible for coordination of work processes and operation of Research, Development and Clinical laboratory areas.

Experience:
  • Minimum: 3-6 years of experience in a regulated environment
Maintain lab areas to ensure Quality System compliance, Safety Compliance, and proper equipment management. Uses independent judgment to execute work and utilize
Interpersonal skills to establish solid internal/cross functional relationships to accomplish goals.

Responsibilities:
  • Manages and support designated laboratory areas by engineers and scientists.
  • Support the Quality Management team in the SOP gaps and present findings for resolution to prepare for the IVD transition.
  • Generate in-house SOPs for programs, devices and projects.
  • Coordinate with System Support Engineers, Facilities, IT, Quality and Safety to ensure laboratory compliance for ISO 13485 and ISO 17035.
  • Trains and documents orientations for new lab users on laboratory organization, workflows, Quality System compliance, SOPs and Safety requirements.
  • Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact user s supervisor if necessary.
  • Ensures all lab supplies available when needed. Manage inventory through forecasting activities, placing purchasing orders, receiving activities, and physical inventory tracking.
  • Addresses laboratory organization/waste/cleanliness issues with laboratory users, General Lab Support, and Facilities to ensure compliance.
Education:
  • Minimum: Bachelor s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience


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