• 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.
• Performs the extraction process on prepared samples in accordance with ISO, USP and JMHLW regulations as directed by study protocols for biocompatibility assays.
• 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.
• 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.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• Maintains an efficient and clean work area by organizing and restocking the sample preparation lab as needed.
• 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, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Performs ethylene oxide processing of study-related materials through the in-house sterilizer.
• Adheres to established company processes.
• Completes chain of custody documentation for test article tracking.
• Responsible for performing routine equipment microbiological monitoring.
• Maintains ancillary records (logbooks, worksheets).
• Communicates test schedule updates to NAMSA Associates or management as needed.
• Responsible for the assessment and completion of GLP study article data retention/archival.
• May assist in receipt and release of lab supplies and inventory.
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks and media preparation.
• Other duties as assigned.