Lab Technician - In Vitro ( Talent Building Community

Overview

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, supporting clients during every step of the product development lifecycle and beyond.

To inspire innovative Med Tech solutions that advance global healthcare, improve patient lives and accelerate client success.

To deliver best-in-class global Med Tech 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.

• Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity and hemocompatibility).
• Strictly adheres to GLP guidelines, including good documentation, labeling and expiration of materials, and 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 with ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with external clients regarding particulate observations or article abnormality, and 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.
• Prepares media and reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies and 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.
• Reviews incoming test articles and paperwork for appropriateness and accuracy, raising concerns to management or Study Directors as required.
• Assists associates with performing routine test article/product preparation according to work instructions.
• Communicates test schedule updates to NAMSA associates or management as needed.
• Maintains ancillary records such as logbooks and 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.
• Provides administrative support when necessary.
• Prepares and maintains sterile glassware for the in‑vitro lab and sample preparation processes, processing glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain-of-custody documentation for test article tracking.
• Monitors laboratory equipment daily, being on‑call and responding to continuous monitoring alarms. If needed, responds in accordance with criteria outlined in Standard Operating Procedures.
• Assists in ordering and stocking supplies subject to approval.
• Assists trainers or becomes a certified trainer to provide on‑the‑job training for basic lab tasks, media preparation, or cell work.
• Other duties as assigned.

• One year of relevant laboratory experience preferred.
• Basic mathematical knowledge is essential for surface area/volume ratio calculations that are part of the sample preparation process.
• Bachelor’s degree in biology or a related scientific field is required; individuals with sufficient relevant work experience may be considered at management’s discretion.

• Employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals.
• Noise level in the work environment is usually…