Quality Control Technician II

About the role

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 organized and inspection-ready work areas.
• Promptly notify supervision or management of nonconformances, deviations, and safety concerns.
• Support equipment validations and assist in drafting or reviewing related equipment documentation as assigned.
• Suggest improvements to standard operating procedures related to histology and laboratory operations.
• Participate in quality improvement processes and projects assigned by management to maintain a safe, organized, efficient, and compliant laboratory.

Essential Skills

• A.S. degree in Biology or a related science, or equivalent work experience.
• 3–5 years of experience in a histology laboratory environment.
• Proficiency in routine histology techniques, including sample receipt, accessioning, grossing, fixation, paraffin embedding, cryo-embedding, paraffin microtomy, and cryo-microtomy.
• Experience with hematoxylin and eosin (H&E) staining and histochemical staining within scope of training.
• Strong quality control testing skills, including accurate observation, documentation, and verification of histology results.
• Hands-on experience with laboratory techniques in a regulated environment, including handling of biological specimens and chemicals.
• Working knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Ability to operate, maintain, and troubleshoot standard and histology-specific laboratory equipment.
• Demonstrated ability to maintain accurate specimen identification and traceability throughout the testing process.
• Proficiency in using laboratory databases, workflow spreadsheets, and controlled logbooks for data entry and recordkeeping.
• Familiarity with FDA, AATB, OSHA, ISO, and USP standards as they relate to laboratory operations.
• Strong attention to detail and organizational skills, particularly in filing, labeling, and record retention.
• Ability to follow standard operating procedures and safety policies consistently.
• Effective communication skills for interacting with auditors, management, and cross-functional team members.
• Ability to work fully onsite and support time-sensitive quality control testing activities.

Additional Skills & Qualifications

• Technical certification as a Histotechnician (HT), Histotechnologist (HTL), or related certification is preferred.
• Experience working in a GxP laboratory environment is preferred.
• Experience supporting Research and Development, Complaints, and Clinical studies is beneficial.
• Familiarity with 6S or similar workplace organization and continuous improvement methodologies.
• Experience participating in internal and external audits within a regulated laboratory setting.
• Ability to contribute to continuous improvement initiatives, including suggesting enhancements to standard operating procedures.
• Comfort working with digital imaging tools for capturing and managing gross specimen images.
• Demonstrated ability to act as a peer reviewer for laboratory records and support quality assurance processes.

Work Environment

This role is 100% onsite and based in a laboratory environment that supports Quality Control, Tissue Services, and Research and Development activities. You will work primarily in a histology laboratory handling donor biopsies, explants, fresh tissues, in-process materials, and final product samples. The environment includes routine use of standard laboratory and histology-specific equipment such as microtomes, cryostats, embedding stations, and imaging systems. You will work with chemicals and biological specimens, following universal precautions, chemical management procedures, and strict safety protocols. The laboratory operates under GLP, GMP, and GDP requirements and adheres to FDA, AATB, OSHA, ISO, and USP standards. The work setting emphasizes organization, cleanliness, and audit readiness, supported by 6S practices and a strong Quality Management System.

Pay

The pay range for this position is $30.00 – $32.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)