Microbiology Technologist

NAMSA•Irvine, CA

3d•$18 - $36

About The Position

NAMSA is an independent company focused on medical device materials safety and provides support throughout the product development lifecycle. The Microbiology Technologist independently prepares routine test articles and products, performs routine testing and calculations, and follows NAMSA standard operating procedures, work instructions, and applicable requirements. The role may involve client contact and responsibility for reviewing incoming test articles and paperwork, recording raw data, and checking laboratory equipment. Depending on applicable testing, the technologist may perform environmental monitoring, clean and disinfect cleanroom suites, operate laboratory equipment, and conduct Kinetic-Chromogenic LAL testing. The position requires work in a GLP/GMP environment and the physical ability to walk, stand, or sit for prolonged periods, as well as extensive computer keyboard use and operation of computer equipment.

Requirements

High school diploma or equivalent and at least 6 years of experience, or a bachelor's degree and at least 1 year of experience.
Sound judgment and effective decision-making skills, with the ability to solve problems or escalate as needed.
Awareness of applicable guidelines and regulations, including USP, ISO, CTFA, and FSA.
Knowledge of the metric system, NAMSA GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
Ability to work in a GLP/GMP environment.

Responsibilities

Independently prepare routine test articles or products, perform routine testing, and complete routine calculations according to NAMSA SOPs and applicable work instructions.
Prepare or participate in preparing test specifications based on applicable standards and client instructions.
Have direct client contact as needed.
Review incoming test articles and paperwork for appropriateness and accuracy, and raise concerns to management as required.
Collect and accurately record raw data in logbooks and on worksheets.
Check laboratory equipment and, as applicable, be on call to respond to continuous monitoring alarms in accordance with SOP criteria.
Perform personal gowning environmental testing and submit organisms from gowning, environmental, and sterility test positives for identification and monthly trending, as applicable.
Operate an autoclave, depyrogenation oven, or other specified laboratory equipment, as applicable.
Perform Kinetic-Chromogenic LAL testing, as applicable.
Perform environmental monitoring and clean and disinfect cleanroom suites, as applicable.
Perform other duties as assigned.