Microbiology Technician 1st Shift

POSITION PURPOSE

This is a safety sensitive position. Responsible for the accurate analysis of incoming raw materials, bulk liquids and finished products utilizing Standard Operating Procedures (SOPs), Work Instructions (WIs), Nice Pak’s Test Methods (PNTM) and Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Assures released raw materials, bulk liquids and finished products have met the required specification criteria prior to release. Investigate failures to determine final disposition. Maintain accurate, complete and traceable documentation related to analysis and disposition.

Essential Functions And Basic Duties

This position requires an individual who is knowledgeable performing microbiological procedures by following test methodology and aseptic techniques. Employees must be well organized and computer literate. The position also interacts with Research & Development, Customer Service, Purchasing Dept., Training Coordinators, Warehouse, and the New York, Indiana, and facilities to help facilitate communication and shared processes.

• Performance of diversified microbiological testing as needed by using NPTMs, SOPs and WIs on raw materials, bulk liquids and finished products.
• Daily collection and testing of DI water to ensure that microbiological specifications are met.
• Perform non-routine microbiological testing such as: bioburden, sterility and validation studies.
• Perform environmental testing as per test methodology.
• Perform microbiological procedures to comply with AAMI guidelines on relation to irradiation of finished products.
• Ensure that all results are accurately recorded in appropriate laboratory logs, LIMS, or other designated forms.
• Order, approve and monitor the purchase of microbiological supplies.
• Specialized testing such as Quarterly Dose Audits, Project Word, and evaluation of new technologies.
• Clean and sanitize laboratory, including hoods and cleanroom, at specified intervals by following appropriate SOP and/or WI.
• Perform calibration, reading and recording of instruments within the Micro Lab.
  
  

The above responsibilities are intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.

Qualifications

EDUCATION/CERTIFICATION:

• Bachelor’s degree in Biology, Microbiology or other related science
  
  

Required Knowledge

• Knowledge of Microbiology methods and the theory and ability to incorporate them into daily tasks and problem solving
  
  

Experience Required

• Minimum of 1 year experience in a laboratory environment (Micro Lab preferred)
  
  

Skills/Abilities

• Ability to demonstrate skill in performing work accurately and precisely and to be able to follow test methodology
• Strong analytical and critical thinking skills
• Ability to do root cause analysis
• Strong computer skills
• Ability to perform work accurately and follow test methodology
  
  

WORKING CONDITIONS

None

No hazardous or significantly unpleasant conditions.