Job description
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. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech 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.
Job Description:
- Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays and pharmacology, toxicology and analytical studies.
- Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
- Receives and logs Sponsor materials for testing. Completes chain of custody documentation for test article tracking.
- Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
- Prepares and maintains sterile glassware for the 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.
- Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed.
- Communicates well with auditors, clients, and other NAMSA Associates.
- Other duties as assigned.
Qualifications & Technical Competencies:
- Experience in a GLP laboratory setting preferred.
- Basic mathematical knowledge is essential for surface area/volume ratio calculations that are part of the sample preparation process."
- An Associate or Bachelor degree in related scientific field is required.
Working Conditions:
- While performing the duties of this job, the Associate is occasionally exposed to sharps and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Eye protection is required in designated areas and when performing specific tasks. The Associate is occasionally exposed to small laboratory animals and may, on rare occasions, be exposed to blood borne pathogens and zoonotic diseases.
- While performing the duties of this job, the Associate is regularly required to stand; walk; reach with hands and arms; use hands to finger, handle, or feel objects, tools, or controls; talk; and hear. The Associate is occasionally required to sit, climb, balance, stoop, kneel, crouch, or crawl. The Associate must occasionally lift and/or move up to 50 pounds. The Associate may be required to view computer monitors and stand for extended periods of time.
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