Senior Laboratory Support Specialist 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:

• \tOversee and coordinate the development of test specifications and test methods for complex test articles with laboratory staff.
• \tPerform technical review of incoming work to determine test appropriateness and sample requirement.
• \tReview incoming test articles, requested tests, and pricing in a timely and accurate fashion.
• \tInvestigate and resolve discrepancies with test samples.
• \tWork with client to develop test specifications for complex testing and provide technical support and direction to the client as needed.
• \tCoordinate the development of test specifications and test methods for routine test articles with laboratory staff.
• \tReview and sign routine GMP reports for technical accuracy and completeness.
• \tReview raw data generated by laboratory studies for technical accuracy and completeness
• \tConduct high level laboratory testing investigations.
• \tMake approved changes to documents (SOP's, reports, protocols, worksheets).
• \tDevelops specialized departmental reports (eg. Environmental monitoring, water testing reports) including trend analysis where applicable.
• \tSupports lab with routine testing as well as evaluation testing for new or updated procedures.
• \tConfirm quality systems are applied in the performance and documentation of laboratory studies.
• \tMay discuss routine testing programs with Clients
• \tOther duties as assigned.

Qualifications & Technical Competencies:

• Qualifications: 4+ years/degree or 8+ years/HS

• Demonstrated knowledge of scientific applications, GLP regulations, experimental design, data evaluation, metric system, medical device testing, and technical writing.
• Awareness of applicable guidelines and regulations such as USDA, USP, FHSA, CTFA, FDA, Tripartite, and ISO standards.

Salary Range: $75,000-$85,000 annually

Working Conditions:

• Physical activities include sitting, walking, and standing for prolonged periods and operate laboratory equipment.
• Extensive use of computer keyboard and mouse.

Pay Range Minimum:
$54,400.00

Pay Range Target:
$80,000.00

Pay Frequency:
Annual

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: