Microbiology Technologist

North American Science Associates, LLC.; Irvine (CA); On-site; USD 28,000 - 34,000; Full time

Job summary

NAMSA, a leading provider of medical device materials testing, seeks an Associate to perform routine test article preparation and testing in a GLP/GMP environment in Irvine, CA. You will handle data recording, equipment operation, and collaboration with clients as needed.

The role requires a High School diploma with 6+ years of experience or a Bachelor degree with 1+ year, exposure to environmental monitoring, and the ability to work in a regulated lab setting.

Qualifications

• High School diploma or equivalent required with 6+ years of experience, or a Bachelor degree with 1+ year of experience.
• Knowledge of GLP/GMP testing and scientific applications.

Responsibilities

• Independently prepare test articles and execute routine testing per NAMSA SOPs.
• Prepare test specifications with standards and client instructions.
• Review incoming test articles and paperwork for accuracy.
• Record raw data accurately in logbooks and worksheets.
• Operate lab equipment and respond to alarms per SOPs.
• Support environmental monitoring and sterility testing as applicable.
• Participate in monthly trending data and data analysis.

Education

High School diploma or equivalent

Bachelor degree

Tools

GLP/GMP procedures

Data recording and logbooks

Laboratory testing

Job description

NAMSA pioneered the industry and 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 industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Compensation Target: $23.00

Job Description: _ 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.

**Target pay range: $20 - $25/hr**

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 escalation 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: Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed.

The compensation grade range for this position is: $18.32 - $35.82Hourly

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

Fair Chance Employment Statement:

At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position.

The following is a list of material job duties for this position:

• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life

A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment.

We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.

NAMSA was founded on the principals of delivering quality customer service, conducting ourselves with integrity, respect for one another, open communication and collaboration.

Whether you have a background in Laboratory Science, Clinical Research, Regulatory Affairs, Quality Assurance, Engineering, or Sales & Business, NAMSA offers exciting opportunities to align with your expertise.