Sr. Lab Support Coordinator
4300 Hacienda Drive Pleasanton, California 94588 | Contract
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
- 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
- Minimum: Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience
- Minimum: 4-6 years of relevant industry experience.
- Preferred: 7-15 years of experience working in an IVD, GMP/ISO regulated environment
- 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