Oakland-Fremont-Pleasanton Metro Area, CA
Responsible for coordination of work processes and operation of Research, Development and Clinical laboratory areas.
- Minimum: 3-6 years of experience in a regulated environment
Interpersonal skills to establish solid internal/cross functional relationships to accomplish goals.
- 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.
- Minimum: Bachelor s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience