Histology Lab Associate Analyst

About the role

This position provides histology support for the Quality, R&D, Clinical, Complaints, and Tissue Services Departments. Responsibilities include all phases of tissue preparation, such as paraffin and frozen technique, routine H&E (Hematoxylin & Eosin) staining, special stains (histochemistry), microscopy, and image analysis. The role also involves maintenance, operation, qualification, and validation of histology equipment, document revisions, and training technicians and peers in histological sample handling, stain techniques, and digital imaging.

The Associate Analyst may have opportunities to develop specialized techniques such as immunohistochemistry and participate in process improvement projects and standard operating procedure revisions.

Responsibilities

• Proficiently perform Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies.
• Prepare specimens with 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.
• Analyze stain results to ensure accuracy and determine if staining is appropriate or if false results were induced during the histological testing process.
• Act as the final quality check on products prior to release by performing Histology analysis and discerning whether findings result from the histological process or production process.
• Collaborate with other histology analysts, Medical Directors, and Scientists to examine test samples, applying gross anatomy understanding to dissect appropriate representative samples and tissue orientation for testing and analysis.
• Peer review sample preparation steps to ensure compliance with standard operating procedures and cGxPs.
• Prepare reagents and solutions for fixation and stain techniques.
• Operate, maintain, and assist in qualification/validation activities of standard laboratory/histology equipment (e.g., microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, water bath, microscope).
• Understand and act on department/project objectives; participate in process improvement projects in a time-sensitive and project-oriented manner.
• Update standard operating procedures as needed and participate in the training and development of others.
• Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with current Good Manufacturing, Good Laboratory, and Good Documentation Practices.
• Adhere to company work standards and Code of Conduct; diligently participate in compliance-related activities, support audits/inspections, and contribute to the overall Quality system.

Requirements

• B.S. in Biology or related science or equivalent work experience.
• Technical Certification (HT, HTL, QIHC, or related) preferred/eligible.
• 4-6 years of histology laboratory experience.
• 1-3 years in histochemistry (Special Stains).
• 1 year of immunohistochemistry experience preferred.

Skills

• Excellence-focused, inquisitive, critical thinking, and decision-making.
• Proficiency in Histology & Histochemistry (Special Stains) Technique.
• Immunohistochemistry Technique (preferred).
• Knowledge of Cell Biology and Tissue Structure.
• Laboratory & Chemical safety, and Blood Borne Pathogens training.
• Computer Skills: Microsoft Word, Excel, PowerPoint, Outlook.
• Organizational skills; ability to organize and prioritize tasks/projects.
• Teamwork and interpersonal skills; ability to communicate effectively both verbally and in writing 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, GCP, or GLP environment.
• Familiarity with AATB, ISO, FDA, and USP regulations/guidelines, and audits.

Benefits

• Healthcare Insurance: Eligible employees and their dependents receive healthcare 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 their 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.