Address
Form of workNAMSA 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:
• May assist associates with performing routine test article/product preparation according to work instructions.
• May assist associates with executing routine testing per NAMSA SOPs, with appropriate data analysis.
• May communicate test schedule updates to NAMSA associates or management as needed.
• May prepare and maintain reagents and/or test articles as required for testing.
• Maintains ancillary records (logbooks, worksheets).
• Routes all positive results or unusual testing occurrences to management.
• 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.
• Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management.
• May execute routine testing per NAMSA SOPs, with appropriate data analysis.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Perform cell production, preparation of media/reagents, maintaining lab supplies, daily monitoring of equipment, and scheduling the lab workload.
• May perform the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Prepares and maintains sterile glassware for the sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Receives and logs Sponsor materials for testing. Completes chain of custody documentation for test article tracking.
• May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• 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.
• Routes all positive results or unusual testing occurrences to management.
• May order and/or stock supplies subject to approval
• May provide on the job training.
• Conduct routine studies independently. May be requested to conduct more involved studies.
• Participate in the improvement of documents, test systems, quality systems, and workflow.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites.
• May communicate with clients as needed to confirm documentation on receipt paperwork is accurate and complete.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• May assist with data entry, analysis of results and report writing for Study Directors.
• May conduct genotoxicity testing.
• Other duties as assigned
Qualifications & Technical Competencies:
• Two years 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 related scientific field is required.
Working Conditions:
• While performing the duties of this job, the employee is regularly exposed to sharps, human and animal blood, and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Safety glasses and hearing protection are required in designated areas and when performing specific tasks.
• "While performing the duties of this job, the employee is regularly required to stand, walk, use hands, talk and hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to sit, climb or balance, and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds, and occasionally lift and/or move up to 75 pounds with assistance. The employee may be required to view computer monitors and stand for extended periods of time.
• Specific vision abilities required by this job include close vision, the ability to adjust focus, exceptional spatial acuity and visual-kinesthetic coordination"
