Sample Prep Technologist

Benefits

Additional Information

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: - Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits). - Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays, pharmacology studies, and toxicology studies. May execute preparation of complex projects. - Regularly utilizes technical expertise to perform and communicate consistent and reproducible preparation processes according to SOPs, protocols, and regulatory guidelines (ISO, USP, JMHLW). - Performs the extraction process on prepared samples in accordance with ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays. - Performs pH and osmolality measurements as needed for testing and material preparation. - Prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed. - Operates, cleans and maintains incubators, autoclaves, ovens, hoods, and other equipment routinely utilized. - Performs preparation of media/reagents, ensures reagents and/or test article are maintained under the appropriate conditions. - Responsible for review of incoming test articles and paperwork for appropriateness and accuracy. Initiate and lead discussions with management or Study Directors to address concerns as they arise. - Maintains an efficient and clean laboratory/work environment for Sample Preparation and In Vitro Testing departments using lean theory. - Communicates with external clients in regards to particulate observations or article abnormality. - Routinely communicates with Study Directors, Quality Assurance and NAMSA Associates about issues, results, or audits. - Responsible for daily monitoring of laboratory equipment. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. - Performs ethylene oxide processing of study-related materials and supplies for In Vivo surgical testing through the in-house sterilizer. - Adheres to established company processes. - May be required to receive and log Sponsor/study materials for testing. Completes chain of custody documentation and ensure traceability of study articles through relevant tracking processes. - Responsible for performing routine equipment microbiological monitoring. - Maintains ancillary records (logbooks, worksheets). - Responsible for the assessment and completion of GLP study article data retention/archival. - Consults with Study Directors and Management regarding technique and methods for sample preparation related procedures. - Conducts regular disposal of hazardous waste ensuring traceability and effective categorization of hazardous materials. - Ensures quality by performing operational reviews of daily work. - 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. Individuals with sufficient relevant work experience may be considered at the discretion of management. Working Conditions: - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk or bend, including for prolonged periods; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move