Histology Lab Analyst

Job Description:

• 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 (histochemisty), immunohistochemistry, microscopy and image analysis.

• Responsible for 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 Histology Analyst may have an opportunity to develop/learn alternate techniques such as advanced immunhistochemistry, in-situ hybridization, electron microscopy, bone histology, method/process validation, Six-Sigma/Lean principles, and document revisions.

• Acts as the final quality check on product prior to product release, by proficiently performing Histology analysis.

• This requires the ability to analyze stain results to discern if false results were induced through the histological process or if the findings resulted from the production process.

• When appropriate the Analyst has the discretion to fail product, report and investigate the OOS through the Quality Management system.

• Evaluation of R&D, Clinical, donor samples, and control tissue as requested.

• Collaboration with Medical Directors and Scientists in examining product, donor tissue, clinical samples, and R&D study samples.

• Applying understanding of gross anatomy coupled with the study purpose to dissect representative samples and determine appropriate stains for histology testing and analysis.

• Proficiently performs Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies.

• Specimen preparation that requires a complex and thorough understanding of tissue structure, as well as a basic understanding of chemistry and physics; and how tissues react under process conditions, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining, special stains (histochemistry), and immunohistochemistry.

• Peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.

• Develop an in-depth knowledge of relevant scientific technologies to improve upon current technique and support the needs of internal customers.

• Draft new and update Standard Operating Procedures as needed.

• Participate in the training and development of others.

• Diligently participate in compliance-related activities as denoted by management, and support the overall Quality System.

• Adhere to company work standards and Code of Conduct.

• Preparation of reagents and solutions for fixation and stain techniques.

• Selection of 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.) as required.

• 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 and manage project activities as assigned by Management, in a time sensitive and project oriented fashion.

QUALIFICATIONS

• B.S. in Biology or related science required or equivalent work experience

• Technical Certification (HT, HTL, QIHC, or related) preferred

• 6-8 years histology laboratory experience, including histochemistry (Special Stains)

• 1-3 years immunohistochemistry experience

• Build Relationships; Customer Orientated; Critical Thinking; Decisions Making; Excellence Focused; Inquisitive; Open and Authentic; Leadership

• Histology, Histochemistry (Special Stains) & Immunohistochemistry (IHC) Technique

• 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 written with all levels of management, internal/external customers, vendors, and those of diverse cultures

• Basic Mechanical skills, and lifting up to 20 lbs

• Good visual skills, manual dexterity and eye-to-hand coordination

• Ability to follow SOP's 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, etc

• GDP training; and experience in working in a GMP/GXPs, GCP, or GLP environment.

• Familiar with AATB, ISO, FDA, and USP regulations/guidelines, and audits.

• LIMS (Laboratory Information Management System) development and operation

• Experience with performing Data Integrity Risk Assessments and System Classifications

• Histology automation and process improvements

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents 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 Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement 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.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities