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Lead Laboratory Technician Sterility Assurance jobs in United States
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NAMSA · 8 hours ago

Lead Laboratory Technician Sterility Assurance

NAMSA is a pioneering company focused on medical device materials for safety, having started testing medical devices before FDA regulations began. The Lead Laboratory Technician Sterility Assurance will oversee laboratory operations, monitor work, perform various testing, and ensure compliance with applicable material specifications and SOPs.
Medical Device
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H1B Sponsor Likelynote

Responsibilities

Schedules and oversees daily operations of assigned laboratory area
Monitors work, coordinates resources, and communicates with other functional areas within NAMSA to address client expectations
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
Maintains all test equipment and supplies for various testing and may assist with procurement of test equipment
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
May have direct client contact as needed
Monitors raw materials and final finished media for conformance with applicable material specifications and SOPs and resolve issues and non-conformances
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 in accordance with criteria outlined in Standard Operating Procedures
May be required to operate specified laboratory equipment as applicable
Other duties as assigned

Qualification

GLP/GMP environmentUSP guidelinesISO standardsScientific applicationsData evaluationMetric system knowledgeProblem solvingEffective decision making

Required

High School diploma or equivalent required and at least 2 years of experience, or Bachelor degree and 1 year of experience
Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed
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

Company

NAMSA

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NAMSA is a medical research organization speeding product development for medical devices, IVDs, regenerative medicine.

H1B Sponsorship

NAMSA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
2020-09-01Acquired

Leadership Team

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Matthew Micowski
SVP & CFO
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Timothy Mitchell
VP - Strategic Partnerships & MRO
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Company data provided by crunchbase