Lab Technologist - In Vitro

Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity and hemocompatibility). Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits). Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing. Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays. Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits. Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized. Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory. Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director. Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required. May assist Associates with performing routine test article/product preparation according to work instructions. May communicate test schedule updates to NAMSA Associates or management as needed. Maintains ancillary records (logbooks, worksheets). May be required to perform personal gowning, environmental testing, and submitting organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing. Adheres to established company processes. May provide administrative support. May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed. Completes chain of custody documentation for test article tracking. Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May assist in ordering and/or stocking supplies subject to approval. May assist trainers or may become a certified tra