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NAMSA · 6 hours ago

Lab Tech (NAMSA Talent Building Community)

Northwood, OH

Full-time

Onsite

New Grad, Entry Level

$14.81/hr - $20/hr

NAMSA is a pioneer in the medical device industry, focusing on materials for safety and providing support throughout the product development lifecycle. The Lab Tech role involves adhering to GLP guidelines, conducting sample preparations for various studies, and maintaining laboratory equipment and supplies.

Medical Device

H1B Sponsor Likely

Responsibilities

Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits)

Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays, pharmacology studies, and toxicology studies

Performs the extraction process on prepared samples in accordance with ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays

May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed

Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized

Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory

Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required

Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed

Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors, Quality Assurance and NAMSA Associates about issues, results, or audits

Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures

Performs ethylene oxide processing of study-related materials through the in-house sterilizer

Adheres to established company processes

Completes chain of custody documentation for test article tracking

Responsible for performing routine equipment microbiological monitoring

Maintains ancillary records (logbooks, worksheets)

Communicates test schedule updates to NAMSA Associates or management as needed

Responsible for the assessment and completion of GLP study article data retention/archival

May assist in receipt and release of lab supplies and inventory

May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks and media preparation

Other duties as assigned

Qualification

GLP laboratory experienceISO regulations knowledgeSample preparation skillsBasic mathematical knowledgeCommunication skillsOrganizational skillsTeam collaboration

Required

An Associate or Bachelor degree in related scientific field is required. Individuals with sufficient relevant work experience may be considered at the discretion of management

Basic mathematical knowledge is essential for surface area/volume ratio calculations that are part of the sample preparation process