Summary:

• This position is intended to perform Quality Control Testing to support acceptance of raw materials and finished product. This position will cross-train to perform all laboratory tests to support dialyzer manufacturing. These tests will include microbiological, chemical, and performance tests. Technician may at the discretion of the QRM Manager have primary responsibility in either the Microbiology Laboratory or the Chemical Laboratory.

Essential Duties and Responsibilities

• 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.

Education:

• Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory
• coursework with 0-2 year's experience.
• Appropriate additional certifications may be required pursuant to state or federal regulatory requirements

Experience/Skills:

• 2+ years of laboratory testing techniques and general knowledge of quality systems required
• Knowledge of microbiological procedures to include media preparation, operation of autoclave, and identification of bacteria required
• Must be able to multi task and work efficiently as a multi functional team and have the ability to perform
• work independently with minimum supervision in Micro, Chem. and Performance Labs.
• The individual must possess good planning, organizational, verbal and written communication skills.
• Must possess good communication and inter-personal skills to communicate with all levels of personnel in
• production, facilities, quality, purchasing and shipping departments and handle confidential and sensitive
• information appropriately.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position 75% of the time, standing 5-6 hours at a time
• The person in this position needs to occasionally move about inside the office and labs to access file cabinets, lab equipment, etc.
• Constantly operates various lab equipment and other office machinery, such as a calculator, copy machine, and computer printer, etc.
• The person in this position frequently communicates with internal and/or external contacts.
• Must be able to exchange accurate information in these situations.
• Requires frequent bending, stooping, reaching above shoulders and below knees and lifting up to 50 pounds
• Potential exposure to blood borne pathogens in this position requires wearing lab coat, gloves, face shield and mask
• Ability to handle repetitive motion work such as pipetting, connecting tubing's, use of keyboard and other electronic devices, etc.
• Ability to work flexible hours including weekends and holidays as required