Associate Quality Analyst

Associate Quality Analyst – Histology Analyst II

The Associate Quality Analyst (Histology Analyst II) performs and documents complex histological testing in support of Quality, R&D, Clinical, Complaints, and Tissue Services functions. This role covers all phases of tissue preparation for paraffin and frozen techniques, including routine H&E staining, special stains (histochemistry), immunohistochemistry, microscopy, and image analysis. The analyst serves as a key quality gate for product release, maintains and qualifies histology equipment, updates documentation, supports audits and inspections, and trains peers and technicians.

This position offers opportunities to learn and develop advanced techniques such as in-situ hybridization, electron microscopy, bone histology, method and process validation, and Lean/Six Sigma principles.

• Act as the final quality check on products prior to release by proficiently performing histology analysis and evaluating stain results to determine whether findings are due to histological processing or production processes.
• Exercise discretion to fail product when appropriate and initiate, report, and investigate out-of-specification (OOS) results through the Quality Management System.
• Evaluate R&D, clinical, donor, and control tissue samples as requested, ensuring accurate and timely histological assessment.
• Collaborate with Medical Directors, scientists, and cross-functional teams to examine product tissue, donor tissue, clinical samples, and R&D study samples.
• Apply knowledge of gross anatomy and study objectives to dissect representative tissue samples and select appropriate stains for histology testing and analysis.
• Proficiently perform histology testing for QC product release samples, clinical complaint cases, donor samples, R&D, and engineering studies, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining, special stains (histochemistry), and immunohistochemistry.
• Conduct peer review of histology sample preparation steps to verify compliance with standard operating procedures and current GxP requirements.
• Develop in-depth knowledge of relevant scientific technologies to enhance current histological techniques and support evolving needs of internal customers.
• Draft, revise, and update Standard Operating Procedures and related controlled documents to reflect current practices and regulatory expectations.
• Participate in the training and development of technicians and peers in histological sample handling, histochemical and immunohistochemical techniques, imaging, and analysis.
• Actively support and adhere to the Quality System by diligently participating in compliance-related activities and following company work standards and Code of Conduct.
• Prepare reagents and solutions for fixation and staining techniques, and select appropriate materials and instrumentation from qualified suppliers.
• Operate, maintain, and qualify or validate standard laboratory and histology equipment such as microtomes, cryostats, tissue processors, embedding units, stainers and cover slippers, balances, incubators, water baths, microscopes, and related instruments.
• Follow laboratory safety standards, including proper biohazard and chemical waste disposal, and comply with current Good Laboratory Practices and Good Documentation Practices.
• Understand and act on departmental and project objectives, manage assigned project activities in a time-sensitive manner, and contribute to process improvement initiatives.
• Support validation and qualification activities for histology processes, methods, and equipment, including participation in data integrity risk assessments and system classifications.
• Contribute to histology automation and process improvement efforts, applying Lean, Six Sigma, or other continuous improvement methodologies where appropriate.
• Support audits and inspections by providing documentation, explaining histology processes, and demonstrating compliance with applicable regulations and standards.
• Use Laboratory Information Management Systems (LIMS) for sample tracking, data entry, and results reporting, and support LIMS development and…