Biological Technician I

Biological TechnicianI

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.

Qualifications
Education:
1 High School or Equivalent

Years of Related Experience:
2-4 Years Related Experience

Knowledge Skills Abilities Certifications/Licenses and Affiliations:
(Include any required computer skills regulatory knowledge certifications licenses languages cognitive and behavioral abilities etc.)
Knowledge of cGMPs and cGDPs required
Basic computer word processing and spreadsheet skills required
Basic laboratory knowledge and experience in an aseptic environment required
Experience working in an FDA regulated environment preferred
Knowledge of SAP inventory management system preferred
Job schedule may require weekend work
Ability to work in a manufacturing environment
Ability to operate automated equipment
Ability to wear lab coat and other personal protective equipment

Responsibility for Others and Internal Interactions
This position reports to the BI Lab Lead
Potential internal interface activities that the position may encounter include:
oWorking with other department such as Quality Master Data R&D Production Planning Manufacturing Engineering etc. to support as required

Physical & Work Environment Requirements
Physical Requirements:
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 talk and hear
Required to walk reach with arms and hands climb or balance and stoop or kneel.
Close vision required

Work Environment:
Travel on the Job: 0-10% Domestic International
Scheduled Work Hours
Shift Work
On Call (Call in for Work)

Approximate Position Requirements
Standing: 10-20%
Kneeling: 0%
Sitting: Up to 80%
Walking: 10-20%

Environmental Health and Safety
All managers and employees shall proactively support ASPs Environmental Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager and employee to:
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.
Provide training to employees when:
Hired
Transferred
New substances processes procedures or equipment are introduced to the workplace and represent a new hazard
Measure safety performance and hold persons accountable for activities and results.
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.
Occupational Hazards:

Ergonomic Risk: Low
Machine Operation
Electrical Hazards
Laser Hazards
Excessive Noise (>85 dB)
Heights (> 6ft)
Hazardous Chemicals/Fumes
Excessive Dust
Bloodborne Pathogen
Biohazards (BBP and parts of LAH)
Extreme Heat/Cold
Other Hazards: Click or tap here to enter text.

Lifting Requirement
Heavy (31-50 lbs)
Ground to knees
Ground to Waist
Ground to Shoulders
Ground to Overhead
Waist to Shoulders
Waist to Overhead

Repetitive Hand Motions
Twisting Motion
Computer Entry
Simple Grasp
Fine Manipulation

Compliance
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.