Sr. Lab Support Coordinator

Pleasanton, California 94588 | Contract

Post Date: 03/22/2018 Job ID: 4026 Industry: R&D

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

 

Description:
  • Responsible for coordination of work processes and operation of research
  • Development and Clinical laboratory areas
  • 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 includes but not limited to:
  • 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

 

Experience:

  • Minimum: 4-6 years of relevant industry experience.
  • Preferred: 7-15 years of experience working in an IVD, GMP/ISO regulated environment

 

Other Qualifications:

  • Strong writing and communication skills
  • Teaching background
  • Possesses excellent people skills with ability to build effective internal/cross-functional relationships.
  • Strong desire to work in a highly regulated environment, with diligent attention to detail to ensure laboratory areas meet regulatory, safety and departmental requirements
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