Sample Preparation Technologist

NAMSA•Minneapolis, MN

23h•$15 - $23

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: • 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: Principal Duties and Responsibilities Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays and pharmacology, toxicology and analytical studies. Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays. Receives and logs Sponsor materials for testing. Completes chain of custody documentation for test article tracking. Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays. Prepares and maintains sterile glassware for the sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed. Operates, cleans and maintains incubators, autoclaves, hoods and other equipment routinely utilized. Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed. Communicates well with auditors, clients, and other NAMSA Associates. Other duties as assigned. Qualifications and Skills 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. Technical Competencies Working Conditions While performing the duties of this job, the Associate is occasionally exposed to sharps and hazardous or caustic chemicals. The noise level in the work environment is usually moderate. Eye protection is required in designated areas and when performing specific tasks. The Associate is occasionally exposed to small laboratory animals and may, on rare occasions, be exposed to blood borne pathogens and zoonotic diseases. While performing the duties of this job, the Associate is regularly required to stand; walk; reach with hands and arms; use hands to finger, handle, or feel objects, tools, or controls; talk; and hear. The Associate is occasionally required to sit, climb, balance, stoop, kneel, crouch, or crawl. The Associate must occasionally lift and/or move up to 50 pounds. The Associate may be required to view computer monitors and stand for extended periods of time. Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed 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 up to 50 pounds (23 kgs). • Regular exposure to laboratory animals, sharps, instrumentation and hazardous or caustic chemicals. Occasional exposure to biohazards, bloodborne pathogens, animal allergens, and zoonotic diseases. • Frequent use of telephone and video conferencing tools. Extensive use of computer keyboard and mouse; prolonged periods of sitting. • Noise level is usually moderate; hearing protection required in designated areas. • Occasional Travel required. • If there is any discrepancy between the above and federal and local legal requirements, the legal requirements apply.

Requirements

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.

Nice To Haves

Experience in a GLP laboratory setting preferred.

Responsibilities

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.
Conducts sample preparation for Sponsor materials as directed by study protocols for in vivo and in vitro biocompatibility assays and pharmacology, toxicology and analytical studies.
Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
Receives and logs Sponsor materials for testing. Completes chain of custody documentation for test article tracking.
Performs the extraction process on prepared samples in accordance to ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
Prepares and maintains sterile glassware for the sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
Operates, cleans and maintains incubators, autoclaves, hoods and other equipment routinely utilized.
Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed.
Communicates well with auditors, clients, and other NAMSA Associates.