Biological Technician I

Fortive•Irvine, CA

About The Position

Biological Technician I Position Summary This position is responsible for spore inoculations and preparation of nutrient agar pour plates in a production environment for Velocity production. Duties and Responsibilities Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position: Responsible for manufacturing subsets of the biological indicator in accordance to cGMP procedures which include but not limited to: Spore inoculation Agar pour plate preparation Preparation of sub-assemblies and raw materials Perform preventative maintenance procedures and maintain laboratory equipment in accordance to established standard operating procedures Perform daily area clean up in accordance to established cGMP procedures Conduct inventory reconciliation checks and restock lab supplies Prepare and review batch records in accordance to cGDP Other responsibilities may include support in test method development or validation, problem investigation or inspection as directed by supervisor Responsible for communicating business related issues or opportunities to next management level For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Perform other work-related duties as assigned by the manager of this role.

Requirements

High School or Equivalent
2-4 Years Related Experience
Knowledge of cGMP’s and cGDP’s required
Basic computer word processing and spreadsheet skills required
Basic laboratory knowledge and experience in an aseptic environment required
Ability to work in a manufacturing environment
Ability to operate automated equipment
Ability to wear lab coat and other personal protective equipment
Must be able to stand for long periods of time
Must be able to lift at least 45 pounds
Must be able to complete repetitive movements for extensive periods of time
Required to talk and hear
Required to walk, reach with arms and hands, climb or balance, and stoop or kneel.
Close vision required

Nice To Haves

Experience working in an FDA regulated environment preferred
Knowledge of SAP inventory management system preferred

Responsibilities

Responsible for manufacturing subsets of the biological indicator in accordance to cGMP procedures which include but not limited to: Spore inoculation, Agar pour plate preparation, Preparation of sub-assemblies and raw materials
Perform preventative maintenance procedures and maintain laboratory equipment in accordance to established standard operating procedures
Perform daily area clean up in accordance to established cGMP procedures
Conduct inventory reconciliation checks and restock lab supplies
Prepare and review batch records in accordance to cGDP
Other responsibilities may include support in test method development or validation, problem investigation or inspection as directed by supervisor
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed Perform other work-related duties as assigned by the manager of this role.