The Histology Technician III is responsible for proficiently performing routine histology technique and employing good documentation practices (GDPs) in recordkeeping to support Quality Control Product Release Testing. This includes but is not limited to all aspects of routine histology, such as: sample receipt and accessioning, initial sample preparation (e.g., rehydration, rinsing, generating labels, etc....), standard grossing and observations, fixation, paraffin embedding, cryo-embedding, paraffin microtomy and cryo-microtomy. Depending on skillset and training, may include Hematoxylin & Eosin (H&E) staining. The Histology Technician III may also perform some aspects of histology testing of donor biopsies, explants, fresh, in-process, or final product samples for Tissue Services, Complaints, and Research & Development (R&D) as instructed and assigned, as well as histochemical stains per skillset and training. Solution preparation, supply management, maintenance and operation of laboratory equipment, instruments, and workstations is expected. Compliance with standard operating procedures (SOPs) and laboratory safety procedures, and maintenance of department databases/files are required. The Histology Technician III is expected to support continuous improvement efforts and the Quality Management System.
Technical Support/Sample Preparation:
• Receive, catalogue, and accession specimens.
• Perform Tissue preparation including rehydration of freeze-dried tissue samples; rinsing of “ready to use” tissue samples; record observations and take digital images of gross specimens/test tissue; specimen grossing and fixation/preservation; tissue processing; paraffin embedding; cryo-embedding; paraffin microtomy; cryo-microtomy, and H&E staining (as assigned)
• Prepare and maintain accurate specimen identification throughout Histology testing process (e.g., specimen containers, cryo vials, cassettes, blocks, slides, images, department data bases, laboratory records and logbooks).
• Operate standard and histology laboratory equipment.
• Assist with gross dictation, measurements, and imaging of clinical samples; and support R&D, Complaints and Clinical studies as assigned.
• Comply with cGxP, GDP and SOPs when entering data into workflow spreadsheets, databases, and controlled logbooks.
• Perform block/slide verifications.
• Become a qualified peer reviewer of lab records for all phases of routine histology; and ensure lab records and logbooks are reviewed and retained.
• Consistent systematic filing of blocks and slides.
• Demonstrate proficient histological technique and recordkeeping to internal/external auditors, management, new and cross-functional employees.
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[strong style="box-sizing: inherit; margin: 0px; padding: 0px;"]Laboratory Maintenance:
• Prepare stock & working solutions, and label in accordance with chemical management procedures.
• Maintain chemical inventory control and storage requirements.
• Observe universal and safety precautions when handling biological specimens and chemicals.
• Adhere to waste disposal regulations for chemicals and biohazard materials.
• Maintain a safe laboratory and current SDS file for chemicals.
• Replenish supplies as needed.
• Routine maintenance on laboratory equipment and workstations.
• Keep supervisor/management informed of laboratory operation status.
• Perform troubleshooting, verification checks, and maintenance of instruments and equipment to maximize performance. Tag equipment out-of-service as required; report and schedule service calls when needed.
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[strong style="box-sizing: inherit; margin: 0px; padding: 0px;"]Compliance:
• Comply with current Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Adhere to FDA, AATB, OSHA, ISO, and USP standards.
• Observe universal and safety precautions when handling biological specimens and chemicals.
• Participate in safety/chemical programming to ensure compliance with/adherence to local and federal regulations.
• Follow established operating procedures, safety policies, and training requirements.
• Adhere to company work standards and Code of Conduct.
• Participate in 6S audits and support internal and external audits.
• Notify supervisor/management of nonconformances/deviations/safety concerns.
• Support equipment validations and draft equipment specifications.
• Suggest improvements to Standard Operating Procedures related to job function.
• Participate in Quality Improvement processes and project as assigned by management to maintain a safe, organized, efficient, and compliant laboratory.
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
A.S. in Biology/related science or equivalent work experience
Technical Certification (HT, HTL or related) eligible, preferred
3-5 years Histology laboratory experience
GXP lab environment experience preferred
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”