Senior Histology Lab Analyst

About the role

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

Responsibilities

• Perform all phases of tissue preparation, including paraffin and frozen technique, routine H&E (Hematoxylin & Eosin) staining, special stains technique (histochemistry), basic and advanced immunohistochemistry, microscopy, and image analysis.
• Review and report test results, develop protocols, conduct process improvement studies, and collaborate with cross-functional colleagues to develop new/alternate techniques such as in-situ hybridization, bone histology, and immunofluorescence.
• Maintain, operate, and qualify/validate histology equipment; revise documents and manage change control.
• Support audits and investigate aberrant test results, nonconformances, and corrective/preventative actions.
• Track team metrics and train technicians/peers in histological sample handling, histochemical/immunohistochemical technique, digital imaging, and analysis.
• Act as the final quality check on product prior to release by performing Histology analysis, with discretion to fail product and report/investigate out-of-specification (OOS) results through the Quality Management system.
• Review data for technical and analytical aspects of testing and make final decisions on product test acceptability.
• Apply understanding of gross anatomy and study purpose to determine, dissect, and orient representative samples for histology testing and analysis.
• Collaborate with Medical Directors and Scientists in testing and evaluation of Quality control test samples, Donor tissue, Complaints, and R&D study samples.
• Understand and act on departmental and project objectives and metrics.
• Lead process improvement projects and manage project activities in a time-sensitive and project-oriented fashion.
• Mentor, train, and develop team members and others.
• Develop in-depth knowledge of relevant scientific technologies and conduct studies to improve current techniques and introduce new ones to support internal customers.
• Draft and update Standard Operating Procedures (SOPs).
• Develop and transfer new techniques as needed.
• Perform process mapping and process/method improvements.
• 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.
• Analyze test results to discern appropriate stain results or false results induced through the histological testing process.
• 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 Manufacturing, Good Laboratory, and Good Documentation Practices.
• Develop compliance awareness in team members and support audit activities.
• Adhere to company work standards and Code of Conduct.
• Participate in compliance-related activities as denoted by management and support the overall Quality System.

Requirements

• B.S. in Biology or related science required; M.S. or higher preferred.
• Technical Certification (HT, HTL, QIHC, or related).
• 8-10 years of histology laboratory experience, including histochemistry (Special Stains).
• 3-5 years of immunohistochemistry experience or other advanced technical expertise.
• In-situ Hybridization (ISH) Technique preferred.
• Cell Biology and Tissue Structure knowledge.
• 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 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 those of diverse cultures.
• Leadership skills and experience.
• Investigative and analytical skills; experience in Laboratory Investigation Reporting.
• 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 required.
• Process Improvement experience (e.g., Six Sigma, LEAN principles).
• Validation/Qualification and method transfer experience is a plus.
• GDP training and experience in working 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.
• Experience with performing Data Integrity Risk Assessments and System Classifications.
• Histology automation and process improvements experience.

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 with premiums 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 who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.