Histology Lab Analyst

About the role

The Histology Analyst II is responsible for proficiently performing and documenting histological testing per standard operating procedures. This individual will provide histology support for the Quality, R&D, Clinical, Complaints, and Tissue Services Departments.

Functions include all phases of tissue preparation, including paraffin and frozen technique, routine H&E (Hematoxylin & Eosin) staining, special stains technique (histochemistry), immunohistochemistry, microscopy, and image analysis. The role involves maintenance, operation, qualification/validation of histology equipment, document revisions, and training technicians and peers in histological sample handling, histochemical/immunohistochemical technique, imaging, and analysis.

The Analyst acts as the final quality check on product prior to release by performing Histology analysis, discerning false results, and determining if findings resulted from the histological or production process. The Analyst may fail product, report, and investigate out-of-specification (OOS) results through the Quality Management system.

Responsibilities

• Evaluate R&D, Clinical, donor samples, and control tissue as requested.
• Collaborate with Medical Directors and Scientists to examine product, donor tissue, clinical samples, and R&D study samples.
• Apply understanding of gross anatomy and study purpose to dissect representative samples and determine appropriate stains for histology testing and analysis.
• Proficiently perform Histology testing for QC product release, Clinical (complaint) cases, donor samples, R&D, and engineering studies.
• Prepare specimens requiring a complex and thorough understanding of tissue structure, chemistry, and physics, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining, special stains (histochemistry), and immunohistochemistry.
• Peer review sample preparation steps to ensure compliance with standard operating procedures and cGxPs.
• Develop in-depth knowledge of relevant scientific technologies to improve current techniques and support internal customers.
• Draft and update Standard Operating Procedures as needed.
• Train and develop peers and technicians.
• Participate in compliance-related activities and support the overall Quality System.
• Adhere to company work standards and Code of Conduct.
• Prepare reagents and solutions for fixation and stain techniques.
• Select appropriate materials and instrumentation from qualified suppliers.
• Operate, maintain, and qualify/validate standard laboratory/histology equipment (microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc.).
• Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with current Good Laboratory and Good Documentation Practices.
• Understand and act on departmental and project objectives; participate in process improvement projects in a time-sensitive and project-oriented fashion.
• Perform data integrity risk assessments and system classifications.
• Support histology automation and process improvements.

Requirements

• B.S. in Biology or related science required or equivalent work experience.
• Technical Certification (HT, HTL, QIHC, or related) preferred.
• 6-8 years of histology laboratory experience, including histochemistry (Special Stains).
• 1-3 years of immunohistochemistry experience.
• Histology, Histochemistry (Special Stains), and Immunohistochemistry (IHC) technique proficiency.
• Knowledge of cell biology and tissue structure.
• Laboratory & Chemical Safety, and Blood Borne Pathogens training.
• Computer Skills: Microsoft Word, Excel, PowerPoint, Outlook required; Trackwise and SAP (preferred).
• Organizational skills and the ability to prioritize tasks/projects.
• Teamwork and interpersonal skills; ability to communicate effectively with all levels of management, internal/external customers, vendors, and diverse cultures.
• Basic mechanical skills and ability to lift up to 20 lbs.
• Good visual skills, manual dexterity, and eye-to-hand coordination.
• Ability to follow SOPs and Work Instructions with attention to detail.
• Strong math skills, aptitude for analysis, and technical writing.
• Microscopic and image analysis experience.
• Process improvement experience (e.g., Six-Sigma, LEAN principles).
• GDP training and experience in a GMP/GXPs, GCP, or GLP environment.
• Familiarity with AATB, ISO, FDA, and USP regulations/guidelines, and audits.
• LIMS (Laboratory Information Management System) development and operation experience.

Skills

• Build Relationships
• Customer Oriented
• Critical Thinking
• Decision Making
• Excellence Focused
• Inquisitive
• Open and Authentic
• Leadership

Benefits

• Healthcare Insurance: Eligible employees and dependents receive coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year of employment.