Quality Control Technician II

Quality Control Technician II (Histology Technician III)

This short-term Quality Control Technician II role focuses on performing routine histology techniques and maintaining high-quality documentation to support product release testing. The position is fully onsite and involves comprehensive sample preparation, histology testing, and laboratory support activities within a regulated environment. You will work with donor biopsies, explants, and various in-process and final product samples, supporting Quality Control, Tissue Services, Complaints, and Research and Development while contributing to continuous improvement and the Quality Management System.

Responsibilities

• Receive, catalog, and accession tissue specimens in accordance with established procedures.
• Perform tissue preparation, including rehydration of freeze-dried tissue samples and rinsing of ready-to-use tissue samples.
• Record observations and capture digital images of gross specimens and test tissues as part of the histology workflow.
• Conduct specimen grossing and fixation or preservation to prepare samples for downstream processing.
• Perform tissue processing, paraffin embedding, cryo-embedding, paraffin microtomy, and cryo-microtomy.
• Perform hematoxylin and eosin (H&E) staining and other histochemical stains as assigned and within scope of training.
• Prepare and maintain accurate specimen identification throughout the histology testing process, including proper labeling of specimen containers, cryovials, cassettes, blocks, slides, images, and associated databases and logbooks.
• Operate standard laboratory and specialized histology equipment in a safe and compliant manner.
• Assist with gross dictation, measurements, and imaging of clinical samples, and support Research and Development, Complaints, and Clinical studies as assigned.
• Enter data into workflow spreadsheets, databases, and controlled logbooks in compliance with cGxP, Good Documentation Practices, and standard operating procedures.
• Perform block and slide verifications to ensure traceability and accuracy of test materials.
• Become a qualified peer reviewer of laboratory records for all phases of routine histology and ensure records and logbooks are properly reviewed, completed, and retained.
• Maintain consistent and systematic filing of blocks and slides to support traceability and audit readiness.
• Demonstrate proficient histological techniques and recordkeeping practices to internal and external auditors, management, and cross-functional team members.
• Prepare stock and working solutions, labeling them according to chemical management procedures.
• Maintain chemical inventory control, including storage conditions and documentation requirements.
• Observe universal and safety precautions when handling biological specimens and chemicals.
• Adhere to waste disposal regulations for chemical and biohazard materials and ensure proper segregation and disposal.
• Maintain a safe laboratory environment and keep Safety Data Sheet (SDS) files current and accessible.
• Monitor and replenish laboratory supplies as needed to support uninterrupted operations.
• Perform routine maintenance on laboratory equipment and workstations according to schedules and procedures.
• Keep supervision and management informed of laboratory operational status, including equipment performance and workflow issues.
• Troubleshoot, verify, and perform basic maintenance of instruments and equipment to maximize performance and minimize downtime.
• Tag equipment as out-of-service when required and coordinate service calls or repairs as needed.
• Comply with current Good Laboratory Practices, Good Manufacturing Practices, and Good Documentation Practices in all work activities.
• Adhere to applicable FDA, AATB, OSHA, ISO, and USP standards while performing laboratory tasks.
• Participate in safety and chemical handling programs to ensure adherence to local and federal regulations.
• Follow established operating procedures, safety policies, and training requirements at all times.
• Adhere to organizational work standards and Code of Conduct, demonstrating ethical and compliant behavior.
• Participate in 6S audits and support internal and external audits by maintaining…