Senior Histopathology Technician

Responsibilities Serve as the Senior Histopathology Technician for a variety of biocompatibility, safety, and efficacy studies for medical devices and associated products in accordance with GLP for Nonclinical Laboratory Studies (Title 21, Part 58). Prepare tissue samples for Pathologist macroscopic and microscopic examinations using various techniques such as fixation, embedding, sectioning, staining, mounting, and imaging. Operate and maintain laboratory equipment, including microtomes, tissue processors, staining stations, and cold storage. Work closely with Quality Assurance (QA) to develop and conduct quality control checks to ensure the precision and reliability of laboratory tests and outcomes. Strictly adhere to laboratory protocols and safety procedures to prevent contamination and ensure the accuracy of test results. Manage laboratory supplies by maintaining inventory and working with the Lab Manager and Procurement to order necessary materials, as needed. Work proactively with Study Director to ensure that any protocol changes related to the processing of tissues are approved and documented in accordance with GLP practices. Work collaboratively with department management, CROs, and Quality Assurance (QA) to exceed Sponsor expectations in the conduct of studies. Ensure that unanticipated responses of study data are corrected, accurately recorded, and verified by working directly with the Study Director to maintain documentation of corrective actions in accordance with regulatory guidelines. Review raw data for technical content and regulatory compliance. Contribute to and prepare GLP study reporting for submission to relevant regulatory agencies to support the company’s applications for clinical use. Participate in continuing education to stay current with the latest techniques and advancements in histopathology. Qualifications Bachelor’s Degree (B.S./B.A.) or equivalent in laboratory science, biology, neuroscience or a scientifically related discipline. Minimum of 5 years of related GLP, clinical laboratory, and/or medical device experience. Applicants with neuro-modulatory and BCI experience are highly desired. Broad understanding of GLP policies and regulatory requirements (FDA, USDA). Demonstrated knowledge of laboratory animal science, toxicology, and histopathology. Ability to handle multiple projects of varying complexity and duration, prioritize work according to company timelines, and drive innovation. Strong understanding of laboratory safety protocols and procedures. Excellent written, reporting, and verbal communication skills with an emphasis on attention to detail. #J-18808-Ljbffr Jobtailor