Biological Technician I

Fortive•Irvine, CA

About The Position

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 with established standard operating procedures Perform daily area clean up in accordance with 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 Perform other work-related duties as assigned by the manager of this role. This position reports to the BI Lab Lead o Working with other department such as Quality, Master Data, R&D, Production Planning, Manufacturing Engineering etc. to support as required Ensure implementation of safety and environmental procedures, guidelines and standards. Evaluate employee compliance and enforce established safety and environmental procedures and rules. Create a safe work area environment, recognize safe activities, and reward good safety performance. Ensure that incidents are investigated to determine root cause, and that corrective actions are taken. Ensure employees wear required protective equipment. Ensure EHS inspections are conducted monthly and corrective actions are implemented. All employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures. This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job.

Requirements

High School or Equivalent (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
Basic computer word processing and spreadsheet skills required
Basic laboratory knowledge and experience in an aseptic environment required
Job schedule may require weekend work
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
This position will be performed in manufacturing environment which requires certain preparation and gowning practices
Must be able to complete repetitive movements for extensive periods of time
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

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 with established standard operating procedures
Perform daily area clean up in accordance with 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
Perform other work-related duties as assigned by the manager of this role.
Working with other department such as Quality, Master Data, R&D, Production Planning, Manufacturing Engineering etc. to support as required
Ensure implementation of safety and environmental procedures, guidelines and standards.
Evaluate employee compliance and enforce established safety and environmental procedures and rules.
Create a safe work area environment, recognize safe activities, and reward good safety performance.
Ensure that incidents are investigated to determine root cause, and that corrective actions are taken.
Ensure employees wear required protective equipment.
Ensure EHS inspections are conducted monthly and corrective actions are implemented.
All employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures.