Biological Technician I

The Biological Technician I position at Advanced Sterilization Products (ASP) is responsible for spore inoculations and preparation of nutrient agar pour plates in a production environment for Velocity production.
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
  

Qualifications

Education:

• 1 High School or Equivalent

Years of Related Experience:

• 2-4 Years Related Experience
  

Knowledge Skills Abilities Certifications/Licenses and Affiliations:

• 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:
• Working with other department such as Quality Master Data R&D Production Planning Manufacturing Engineering etc. to support as required

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