Associate Microbiologist

NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.

We have become the industrys premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization whose:
Mission is to make a scientific contribution to every medical device in the world.
Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
Values have stood the test of time.
Above all else, conduct ourselves with integrity


Job Description:

Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions.
Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
May have direct client contact as needed.
Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
Accurately collects and records raw data in logbooks and on worksheets.
Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in SOPs.
Perform personal gowning environmental testing, submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.
Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
Perform Kinetic-Chromogenic LAL testing as applicable.
Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable.
Other duties as assigned.


Qualifications & Technical Competencies:



Principal Duties and Responsibilities

Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions.
Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
May have direct client contact as needed.
Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
Accurately collects and records raw data in logbooks and on worksheets.
Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in SOPs.
Perform personal gowning environmental testing, submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.
Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
Perform Kinetic-Chromogenic LAL testing as applicable.
Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable.
Other duties as assigned.


Qualifications and Skills

High School diploma or equivalent required and at least 6 years of experience, or Bachelor degree and at least one year of experience
Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed


Technical Competencies

Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
Knowledge of metric system, NAMSA GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
Ability to work in GLP/GMP environment.


Working Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
Extensive use of computer keyboard; operate computer equipment.

Working Conditions:


The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
Extensive use of computer keyboard; operate computer equipment.