Apply on Employer Site

NAMSA · 2 weeks ago

Senior Lab Technologist-In Vitro (Sign on Bonus Eligible)

Northwood, OH

Full-time

Onsite

Mid, Senior Level

3+ years exp

NAMSA is a pioneer in the medical device materials industry, focusing on safety testing since 1976. The Senior Lab Technologist-In Vitro role involves executing routine testing, adhering to GLP guidelines, and maintaining cell lines, while also communicating with clients and managing laboratory supplies.

Medical Device

H1B Sponsor Likely

Responsibilities

Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity, hemocompatibility and genotoxicity)

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

Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing

Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays

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

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

Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director

May assist associates with performing routine test article/product preparation according to work instructions

Assist with creating and communicating schedules for the Associates appropriate for the lab workload. Provide any scheduling updates to NAMSA Associates or management as needed

Maintains ancillary records (logbooks, worksheets)

May be required to perform personal gowning, environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing

Adheres to established company processes

May provide administrative support

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

Completes chain of custody documentation for test article tracking

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

Assist with ordering and/or stocking supplies subject to approval

May be certified as a trainer to provide Associates with on the job training. Documents training activities and completes certification of Associates. Trains Associates on Hemocompatibility and Cytotoxicity

Conduct routine studies independently. May be requested to conduct more involved custom studies

Participate in the creation and improvement of documents, test systems, quality systems, and workflow

May perform Environmental Monitoring, clean and disinfect cleanroom suites

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

May conduct genotoxicity testing

Other duties as assigned

Qualification

GLP guidelinesCytotoxicity testingGenotoxicity testingISO regulationsData analysisLIMS proficiencyTechnical writingTeam collaborationProblem-solvingCommunication skills

Required

Bachelor's degree in scientific discipline appropriate for hiring department and at least three years of related laboratory experience

Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP

Knowledge of metric system, scientific applications, experimental design, and data evaluation

Can write technical documents and communications (SOPs, protocols, Trackwise records) with minimal management input

Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department

Ability to work in GMP/GLP environment

Company

NAMSA

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

Founded in 1967

Northwood, Ohio, USA

1001-5000 employees

http://www.namsa.com/

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)