Job Description:

• Performs required tests in the performance, microbiological, and chemical labs on finished dialyzers and
• raw materials to support product acceptance. This includes performing analyses, calibrations and maintenance on multiple lab equipment/instruments and entering results in the Guardus system. May assist with environmental and process media monitoring by taking samples and testing as required by defined procedure. Maintains cleanliness of labs and lab instruments
• Analyze issues on out of specification (OOS) conditions and unusual trends and immediately initiate NCR or deviation and notify Lab Supervisor/Quality Engineer and/or QRM Manager.
• Orders and maintains lab supply stock (reagents, chemicals, standards etc.) to maximize efficiency.
• Revises work instructions and templates to ensure ISO, FDA, and Gambro Corporate compliance. Creates new work instructions for new projects, as requested by management.