Quality Assurance Specalist III

Quality Assurance Specialist III / Senior Histology Analyst

The Quality Assurance Specialist III / Senior Histology Analyst performs and documents complex histological testing in compliance with cGxP guidelines and regulations. This role provides advanced histology support to Quality, R&D, Clinical, Complaints, and Tissue Services functions, covering all phases of tissue preparation, staining, microscopy, and image analysis. The position also leads data review and test result release, protocol development, process improvement initiatives, equipment qualification and validation, and supports audits and quality systems within a highly regulated laboratory environment.

Responsibilities:

• Perform and document histological testing in accordance with standard operating procedures and cGxP guidelines.
• Support Quality, R&D, Clinical, Complaints, and Tissue Services teams with expert histology services and guidance.
• Execute all phases of tissue preparation, including fixation, embedding, microtomy, and both paraffin and frozen section techniques.
• Perform routine H&E (Hematoxylin & Eosin) staining and a wide range of special stains (histochemistry).
• Conduct basic and advanced immunohistochemistry (IHC) procedures and interpret results.
• Utilize microscopy and digital image analysis to evaluate tissue sections and document findings.
• Review generated data for accuracy and completeness and make final decisions regarding test acceptability and product release.
• Develop, optimize, and implement new protocols and methods, including in-situ hybridization, bone histology, and immunofluorescence, in collaboration with cross-functional colleagues.
• Lead and participate in process improvement studies, including histology automation and continuous improvement initiatives.
• Operate, maintain, qualify, and validate histology and laboratory equipment to ensure reliable performance.
• Prepare and execute equipment validation and qualification protocols in alignment with regulatory and quality requirements.
• Update, revise, and implement standard operating procedures and controlled documents, ensuring robust document control and change control practices.
• Support and participate in internal and external audits, inspections, and compliance initiatives related to histology and quality systems.
• Investigate aberrant test results, nonconformances, and laboratory issues using strong root-cause analysis and laboratory investigation practices.
• Contribute to corrective and preventive actions (CAPA) and follow-through on implementation and effectiveness checks.
• Track and contribute to team metrics and performance indicators related to laboratory operations and quality.
• Train, mentor, and develop technicians and peers in histological sample handling, histochemistry, immunohistochemistry, digital imaging, and analysis.
• Provide leadership support to the laboratory team and, when needed, represent the department in meetings and support management activities.
• Participate in LIMS (Laboratory Information Management System) development and operation to ensure accurate sample tracking and data integrity.
• Perform data integrity risk assessments and system classifications for laboratory systems and processes.
• Ensure work complies with GMP, GLP, GCP, and other relevant regulatory and quality standards.
• Collaborate with cross-functional teams to transfer methods, support validation activities, and align on best practices.
• Contribute to continuous improvement of laboratory workflows, throughput, and automation while maintaining high quality standards.

Essential

Skills:

• Bachelor's degree in Biology or a related science, or equivalent work experience.
• 6–8 years of histology laboratory experience, including hands-on histochemistry (special stains).
• 1–3 years of immunohistochemistry (IHC) experience, with the ability to independently perform and troubleshoot IHC assays.
• Extensive experience with tissue preparation, fixation, embedding, microtomy, and routine and special staining procedures.
• Demonstrated proficiency in histochemistry (special stains) and interpretation of staining quality.
• Experience with microscopy and digital image analysis for evaluation of tissue sections.
• Experienc…