Laboratory Study Technical Specialist

NAMSA•Atlanta, GA

1d•Onsite

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. The Laboratory Study Technical Specialist drives the coordination and development of test specifications, protocols, final summary reports and test methods for routine and complex test articles, including validation projects, across laboratory operations. This role supports routine testing and validation project timelines, ensures compliance with regulatory requirements, and participates in client consultations to provide technical and validation expertise. The specialist also investigates discrepancies, performs technical reviews of incoming samples, assesses project scope for proposals, reviews raw data, leads high-level investigations, and provides technical support to laboratory units. They are also responsible for driving procedural changes and process improvement projects.

Requirements

Bachelor’s degree in a related field, and a minimum of 6 years of relevant experience; or Master’s degree in a related field, and a minimum of 4 years of relevant experience.
Fluency in English and local language, if different, required.
Demonstrated knowledge of scientific applications, GMP/GLP regulations, experimental design, data evaluation, metric system, medical device and pharmaceutical testing, and technical writing.
Knowledge and experience with validation standards and regulations for medical devices ad pharmaceuticals.
Awareness of applicable guidelines and regulation, such as, USDA, USP, FHSA, CTFA, FDA, AAMI, ISO, EU MDR and others, as necessary and applicable.

Responsibilities

Drive the coordination and development of test specifications, protocols, final summary reports and test methods for routine and complex test articles, including validation projects, across laboratory operations.
Support routine testing and validation project timelines.
Ensure testing of routine and complex test articles, including validation projects, are in compliance with regulatory requirements.
Participate in consultation calls, and collaborate with clients, to provide technical and validation expertise in the medical device and pharmaceutical industries, related to routine and validation studies.
Investigate and resolve discrepancies with test samples.
Perform technical review and evaluation of incoming test samples to determine test appropriateness, test procedures and sample requirements, particularly for complex test articles, including validation projects, across laboratory operations.
Assess scope of routine and validation projects, participate in development of proposal generation and pricing.
Review raw data generated by laboratory studies and sign final reports across laboratory operations for technical accuracy and completeness.
Participate in and lead high level laboratory testing investigations.
Provide technical support to all units in laboratory operations.
Drive procedural changes, worksheet updates, and process improvement projects across laboratory operations.
May participate and support equipment validation projects across laboratory operations.
Other duties as assigned.