Quality Assurance (Qa) Specialist III

Title : Histology Laboratory Associate AnalystLocation : Branchburg, NJDuration: 06+ MonthsPay Range: $41/hr - $46.96/hrReports to: Mgr. Histology LaboratoryDepartment: Quality Control Laboratories – HistologyJob Summary The Histology Associate Analyst 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 (histochemistry), microscopy, and image analysis. This individual is also responsible for maintenance, operation, qualification/validation of histology equipment, document revisions, training technicians and peers in histological sample handling, stain technique, and digital imaging. The Associate Analyst may have an opportunity to develop/learn specialized techniques such as immunohistochemistry and be involved in process improvement projects and standard operating procedure/document revisions.Supervisory ResponsibilityKey Duties and ResponsibilitiesHistology Testing – 50%

• Proficiently performs Histology testing for QC product release test samples, Clinical (complaint) cases, donor samples, R&D, and engineering studies.
• Performs specimen preparation requiring 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 as applicable with skillset and training.
• Analyzes stain results for accurate and appropriate staining and determines if staining is appropriate or if false results were induced through the histological testing process.

Quality Check and Histology Analysis – 25%

• Acts as the final quality check on product prior to product release by proficiently performing Histology analysis.
• Analyzes stain results to discern if false results were induced through the histological process or if the findings resulted from the production process.
• Collaborates with other histology analysts, Medical Directors, and Scientists in examining test samples and applying gross anatomy understanding in conjunction with the study purpose to dissect appropriate representative samples and tissue orientation for histology testing and analysis.
• Performs peer review of sample preparation steps of the histology process to ensure compliance with standard operating procedures and cGxPs.

Laboratory Equipment and Reagents – 10%

• Prepares reagents and solutions for fixation and stain techniques.
• Operates, maintains, and assists in qualification/validation activities of standard laboratory/histology equipment, including microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc., as required.

Process Improvement and Training – 10%

• Understands and acts on department/project objectives.
• Participates in process improvement projects in a time-sensitive and project-oriented fashion.
• Updates standard operating procedures as needed.
• Participates in the training and development of others.

Compliance and Quality – 5%

• Follows Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and complies with current Good Manufacturing, Good Laboratory, and Good Documentation Practices.
• Adheres to company work standards and Code of Conduct.
• Diligently participates in compliance-related activities.
• Supports audits/inspections and the overall Quality system as denoted by management.

Job Qualifications – Minimum RequirementsEducation and Experience

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

Leadership Skills

• Excellence Focused
• Inquisitive
• Open and Authentic

Professional Skills

• Build Relationships
• Communication
• Critical Thinking
• Customer Oriented
• Decision Making

Other Professional Skills

• Histology & Histochemistry (Special Stains) Technique
• Immunohistochemistry Technique, preferred
• Cell Biology and Tissue Structure knowledge
• Laboratory & Chemical safety, and Blood Borne Pathogens training
• Computer Skills: Client Word, Excel, PowerPoint, Outlook required
• Organizational Skills; 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 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, etc.
• GDP training and experience working in a GMP, GCP, or GLP environment
• Familiar with AATB, ISO, FDA, and USP regulations/guidelines and audits