Job Summary:

• 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 immune histochemistry, in-situ hybridization, electron microscopy, bone histology, method/process validation, Six-Sigma/Lean principles, and document revisions.

Key duties and responsibilities: describe scope:

• 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.
• 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
• ecalcification, 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, water bath, 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.5%

job Qualifications (Minimum Requirements):

The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Education and Experience

• 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