• Job Description

  Req#: R4736

  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:

  • Prepare all testing/test article and animals according to written instructions and protocols.
  • Review pour/decant data for accuracy.
  • Execute routine testing per NAMSA SOPs, with appropriate data analysis.
  • Communicate test schedule updates to NAMSA management as needed.
  • Prepare and maintain reagents and/or test articles as required for testing.
  • Maintain ancillary records (log books, worksheets).
  • Maintain relevant supplies and equipment used in routine testing.
  • Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to management.
  • Conduct daily health observations.
  • Administer the test article or extract according to written instructions and protocols.
  • May assist in the training of new associates.
  • May be required to conduct necropsies.
  • Provide suitable care for the welfare of the animals according to written instructions and protocols.
  • Responsible for checking laboratory equipment.
  • May be required to order laboratory supplies.
  • May execute FDA ASCA testing per NAMSA SOPs
  • Interact with client/regulatory auditors.

  Qualifications & Technical Competencies:

  Principal Duties and Responsibilities
  • May prepare all testing/test article and animals according to written instructions and
  protocols.
  • May execute routine testing per NAMSA SOPs, with appropriate data analysis.
  • May communicate test schedule updates to NAMSA management as needed.
  • May prepare and maintain reagents and/or test articles as required for testing.
  • Maintain ancillary records (log books, worksheets).
  • Maintain relevant supplies and equipment used in routine testing.
  • Routes all positive results or unusual testing occurrences to management.
  • May be required to conduct daily health observations.
  • May be required to administer the test article or extract according to written instructions
  and protocols.
  • May be required to conduct necropsies.
  • May be required to provide suitable care for the welfare of the animals according to written
  instructions and protocols.
  • 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.

  Qualifications and Skills
  Bachelor’s degree in scientific discipline or a high school diploma with at least 3 years of
  relevant laboratory experience.

  Technical Competencies
  • Awareness of applicable guidelines and regulations appropriate for primary department, these
  may include USDA, USP, Tripartite, FHSA, CTFA, FSA, ICH, EP, and/or JP.
  • Knowledge of metric system, scientific applications, experimental design, and data evaluation.
  • Ability to work in a GLP/GMP environment.
  • Working knowledge of applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as
  appropriate per primary department.

  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 include close vision, color vision, depth perception, and ability to
  adjust focus.
  • Physical requirements include frequently lifting up to 25 pounds or more on occasion.
  • Employee must be able to talk and hear.
  

  Working Conditions:

  • Physical activities include walking, sitting and standing for prolonged periods.
  • Extensive use of computer keyboard and mouse.
  • Vision abilities include close vision, color vision, depth perception, and ability to adjust focus.
  • Physical requirements include frequently lifting up to 25 pounds or more and to climb a four foot ladder if necessary.
  • Must be able to talk and hear.

• About the company

  Helping medical device Sponsors improve healthcare since 1967, NAMSA is the only 100% medical device-focused, full continuum Contract Research Organization.

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