Associate Scientist

NAMSA•St. Paul, MN

1d•$54,400 - $69,000

About The Position

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: • Ensures the testing and analysis of client samples is accomplished in a timely and accurate manner. • May perform both routine and non-routine assignments, utilizing various types of instrumentation and matrices. • Participates in regulatory compliance activities (i.e., audits and inspections) and occasional technical interaction with clients. • May prepare reports such as deviations, laboratory investigations and CAPAs as needed. • Perform equipment maintenance and troubleshooting; investigate and facilitate the resolution of any instrument failures. • Participate in various tasks including method design, development, validation and analysis. • Perform custom protocols and validations within operational area and write final reports to support these activities. • Determine opportunities to increase efficiency and implement process improvements. • May develop and write protocols and SOPs with limited or no assistance. • Other duties as assigned.

Requirements

Minimum of 3 years of relevant experience with a BS/BA
PhD or Masters with relevant work study experience
Strong working knowledge of ISO 10993-12 and 10993-18
Chromatography and analytical instrumentation experience required
Ability to perform moderate to complex mathematical calculations
Demonstrated wet chemistry skills
Proficient in oral & written communication
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Regulated lab experience preferred

Nice To Haves

Mass spectroscopy data processing experience preferred
Polymer and/or Bioanalytical experience preferred
Method development and analytical method validation experience preferred

Responsibilities

Ensures the testing and analysis of client samples is accomplished in a timely and accurate manner.
May perform both routine and non-routine assignments, utilizing various types of instrumentation and matrices.
Participates in regulatory compliance activities (i.e., audits and inspections) and occasional technical interaction with clients.
May prepare reports such as deviations, laboratory investigations and CAPAs as needed.
Perform equipment maintenance and troubleshooting; investigate and facilitate the resolution of any instrument failures.
Participate in various tasks including method design, development, validation and analysis.
Perform custom protocols and validations within operational area and write final reports to support these activities.
Determine opportunities to increase efficiency and implement process improvements.
May develop and write protocols and SOPs with limited or no assistance.
Other duties as assigned.