Senior Lab Technician - Sterility Assurance

North American Science Associates, Inc.; Irvine (CA); Hybrid; USD 33,000 - 36,000; Full time

Job summary

NAMSA, based in Irvine, CA, seeks a laboratory technician to perform testing in accordance with SOPs, prepare reagents, and maintain equipment in a GLP/GMP setting. The role emphasizes precise data collection and adherence to material specifications.

The ideal candidate has a high school diploma or equivalent (or a bachelor's degree) and strong problem-solving skills with the ability to interpret results and support analyses. Target pay is $24.00–$26.00 per hour.

Qualifications

• Must have a high school diploma or equivalent (or a bachelor’s degree).
• Good judgment and problem-solving abilities with the ability to escalate as needed.
• Experience or familiarity with GLP/GMP environments and relevant guidelines.

Responsibilities

• May perform various testing independently in accordance with SOPs and guidelines.
• Performs routine calculations and may participate in analyzing and interpreting results.
• Maintain all test equipment and supplies for various testing.
• Clean glassware and prepare reagents for use in laboratory testing.
• May be responsible for extractions, including test article and control preparation, animal holding and preparation and solution preparation.
• May be responsible for chain of custody, delivery of samples, filing and sample distribution/shipping.
• Accurately collect and record raw data in logbooks and on worksheets.
• Maintain clean workspace, testing supplies, and equipment.

Skills

Decision making

Data interpretation

Education

High School diploma or equivalent

Bachelor's degree

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: $25.00

Job Description:

• May perform various testing independently in accordance with SOPs and utilizing applicable work instructions, standards or guidelines.
• Performs routine calculations and may participate in analyzing and interpreting results.
• Maintain all test equipment and supplies for various testing
• Clean glassware and prepare reagents for use in laboratory testing.
• Perform routine disposal of laboratory waste including disposal of test articles.
• Assist with making solutions and preparing reagents.
• Assist in the preparation of items for testing.
• Monitor raw materials and final finished media for conformance with applicable material specifications and SOPs.
• May be responsible for extractions, which may include: test article and control preparation, animal holding and preparation and solution preparation.
• May be responsible for chain of custody, delivery of samples, filing and sample distribution/shipping.
• Accurately collect and record raw data in logbooks and on worksheets.
• Maintain clean workspace, testing supplies, and equipment
• May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable and in accordance with criteria outlined in Standard Operating Procedures.
• May be required to operate specified laboratory equipment as applicable.
• Maintains an efficient workflow process relative to sample prioritization.
• Other duties as assigned.

Qualifications & Technical Competencies:

• High School diploma or equivalent required and at least 1 year of experience, or Bachelors degreee and 0 years of experience.
• Sound judgment with effective decision making skills and the ability to solve problems or elevate 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

Target pay: $24.00 - 26.00/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.

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.

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.

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.

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.