Lab Technologist - In Vitro

About the Company

NAMSA pioneered the medical device materials testing industry and was the first independent company in the world to focus solely on medical device safety. Founded before the U.S. Food and Drug Administration began regulating such products in 1976, NAMSA has shaped the industry by developing the test methods that govern it. As the industry’s premier provider, NAMSA supports clients throughout the entire product development lifecycle and beyond.

Vision: To inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success.

Mission: To deliver best-in-class global MedTech development solutions through our people, expertise, and technology.

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.

Responsibilities

• Perform routine test article/product preparation according to work instructions.
• Execute routine testing per NAMSA SOPs, including appropriate data analysis.
• Perform routine calculations, interpret results, and escalate positive results or unusual occurrences to management.
• Provide on-the-job training as needed.
• Ensure testing and test article preparation are completed within due dates.
• Prepare and maintain cell lines and reagents required for testing, as applicable to the primary department.
• Maintain relevant supplies, materials, and equipment used in routine testing.
• Maintain ancillary records (logbooks, worksheets).
• Conduct routine studies independently; may be requested to conduct more involved studies.
• Participate in the improvement of documents, test systems, quality systems, and workflow.
• Check laboratory equipment, respond to continuous monitoring alarms, and be on-call as required by SOPs.
• Perform environmental monitoring, clean and disinfect cleanroom suites.
• Order and/or stock supplies subject to approval.
• Perform personal gowning environmental testing and submit organisms from gowning, environmental, and sterility test positives for identification and monthly trending data.
• Review incoming test articles and paperwork for appropriateness and accuracy; escalate concerns to management.
• Operate autoclave as required.

Requirements

• Bachelor’s degree in a scientific discipline appropriate for the hiring department and at least two years of related laboratory experience, or a high school diploma with at least six years of relevant laboratory experience.

Skills

• Awareness of applicable guidelines and regulations (e.g., USP, ISO, CTFA, FSA, ICH, EP, JP).
• Knowledge of the metric system, scientific applications, experimental design, and data evaluation.
• Ability to draft technical documents and communications (SOPs, protocols, Trackwise records).
• Proficiency with applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.).
• Ability to work in a GMP/GLP environment.

Working Conditions

• Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
• Vision abilities required: close vision, color vision, depth perception, and ability to adjust focus.
• Frequently lift up to 25 pounds; occasionally lift up to 50 pounds and, with assistance, up to 75 pounds.
• Must be able to talk and hear.
• Regular exposure to sharps, human and animal blood, and hazardous or caustic chemicals.
• Moderate noise levels in the work environment; safety glasses and hearing protection required in designated areas and during specific tasks.
• May require extended periods of standing or viewing computer monitors.
• Specific vision requirements include exceptional spatial acuity and visual-kinesthetic coordination.