BiomaterialsProductionLabTechnician

Comprehensive understanding of all applicable MSOP’s, QCSOP’s, GMP (Good Manufacturing Practices), and line clearance requirements., Maintain proper documentation per GDP (Good Documentation Practices) by filling out work orders correctly and accurately recording accepted and rejected quantities., Keep workspace clean and organized., Visual inspection of defects and record rejects on device history record (DHR)., Perform biomaterials formulation mixing processes with minimal or no errors., Perform SAP confirmation of materials used during material formulation., Capture critical data from curing, extraction and drying processes process and upload to analyze and interpret for verification of design specifications., Demold biomaterial sheets from heated glass molds while incurring minimal damage/rejects., Process biomaterial sheets through a semi-automated punch and die while carefully aligning the material to maximize yield., Perform button extraction with methanol in Soxhlet Extraction set-up and periodically check on extraction status., Perform silicone tubing and gasket extraction., Perform methanol and hydrophobic button isolation (shakeout) and drying processes., Loading drying ovens and initiate programs. Verify correct process and program input parameters., Inspect, confirm final quantities and package finished buttons., Perform dimensional inspection for button diameter and thickness., Perform physical inventory of raw materials and supplies. Upload inventory in to database., Submit Material Request Forms or Kanban form to maintain raw material inventory., Monitor raw material inventory levels and submit scrap form requests for destruction., Elevate any process non-conformances to leads, supervisors, or quality control., Ensure that all finished product meets quality standards and specifications., Maintains the work area and equipment in a clean orderly condition and follows safety regulations., Working knowledge and understanding of all applicable Standard Operating Procedures and supporting documentation., Ability to use commonsense to find resolution when faced with challenges to carry out instructions., Basic algebra and basic statistical analysis of data sets including standard deviation and related to quantities and chemical concentrations calculations., Ability to read and interpret documents such as safety rules, operating/maintenance instructions and procedure manuals., Regularly required to walk, sit, stand, bend and twist., Requires some lifting and carrying of equipment of 25 pounds or mildly greater., Vision abilities required for this job close vision, distance vision, peripheral vision and depth perception and the ability to adjust focus., Repetitive use of hands, controlled grasping and fine manipulation., Must be well-organized and multi-task oriented., Chemistry related bachelor’s degree (B. A. /B. S. ) from a four-year college or or a chemistry related associate degree from a college or university with twelve to eighteen months of related experience and/or training., Working knowledge of MS Office software programs such as Word, Excel and Outlook.