Microbiology Technologist at NAMSA in Irvine, California

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.

Job Description:

• \tMay perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions.
• \tAccurately collects and records raw data in logbooks and on worksheets.
• \tMay be 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 Standard Operating Procedures.
• \tMay be required to perform required specific testing as applicable.
• \tMay be required to operate specified laboratory equipment.
• \tMay perform Environmental Monitoring, clean and disinfect cleanroom suites (required as applicable).
• \tOther 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.

Salary Range: $20-25/hr

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.

Pay Range Minimum:
$17.79

Pay Range Target:
$24.00

Pay Frequency:
Hourly

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.

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: