Senior Lab Support Coordinator in Pleasanton, CA at Apex Life Sciences

Date Posted: 3/22/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
    Other
  • Experience:
    4 to 6 years
  • Date Posted:
    3/22/2018
  • Job ID:
    833267

Job Description


Description:

  • Responsible for coordination of work processes and operation of RSS-Pleasanton 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.