Associate Quality Analyst II

Job-ID29320213Reference26-26340 Job Description: The Histology Analyst II is responsible for proficiently performing and documenting histological testing per standard operating procedures. This individual will provide histology support for the Quality, R&D, Clinical, Complaints, and Tissue Services Departments. Functions include all phases of tissue preparation, including paraffin and frozen technique, routine H&E (Hematoxylin & Eosin) staining, special stains technique (histochemisty), immunohistochemistry, microscopy and image analysis. This individual is also responsible for maintenance, operation, qualification/validation of histology equipment, document revisions, and training technicians and peers in histological sample handling, histochemical/immunohistochemical technique, imaging and analysis. The Histology Analyst may have an opportunity to develop/learn alternate techniques such as advanced immunhistochemistry, in-situ hybridization, electron microscopy, bone histology, method/process validation, Six-Sigma/Lean principles, and document revisions. Responsibilities: Acts as the final quality check on product prior to product release, by proficiently performing Histology analysis. This requires the ability to analyze stain results to discern if false results were induced through the histological process or if the findings resulted from the production process. When appropriate the Analyst has the discretion to fail product, report and investigate the OOS through the Quality Management system. Evaluation of R&D, Clinical, donor samples, and control tissue as requested. Collaboration with Medical Directors and Scientists in examining product, donor tissue, clinical samples, and R&D study samples.60% Applying understanding of gross anatomy coupled with the study purpose to dissect representative samples and determine appropriate stains for histology testing and analysis. Proficiently performs Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies. Specimen preparation that requires a complex and thorough understanding of tissue structure, as well as a basic understanding of chemistry and physics; and how tissues react under process conditions, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining, special stains (histochemistry), and immunohistochemistry. Peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.20% Develop an in-depth knowledge of relevant scientific technologies to improve upon current technique and support the needs of internal customers. Draft new and update Standard Operating Procedures as needed. Participate in the training and development of others. Diligently participate in compliance-related activities as denoted by management, and support the overall Quality System. Adhere to company work standards and Code of Conduct. 10% Preparation of reagents and solutions for fixation and stain techniques. Selection of appropriate materials and instrumentation from qualified suppliers. Operate, maintain,and qualify/validate standard laboratory/histology equipment (microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc.) as required. Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with current Good Laboratory and Good Documentation Practices. 5% Understand and act on departmental and project objectives; participate in process improvement projects and manage project activities as assigned by Management, in a time sensitive and project oriented fashion. Qualification: B.S. in Biology or related science required or equivalent work experience Technical Certification (HT, HTL, QIHC, or related) preferred 6-8 years histology laboratory experience, including histochemistry (Special Stains) 1-3 years immunohistochemistry experience

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