Histology Laboratory Analyst

Location: Branchburg, NJ 08876
Duration: 6-month contract (possible extension based on business needs and budget)

Pay

• Histology Laboratory Associate Analyst: $25.00 – $30.00 per hour
• Histology Laboratory Analyst II: $25.00 – $30.00 per hour
• Senior Histology Laboratory Analyst: $40.00 – $46.00 per hour

Requirements

• B.S. in Biology or related science required (or equivalent work experience); M.S. or higher preferred
• Technical certification (HT, HTL, QIHC, or related) preferred
• Histology Laboratory Associate Analyst: 4–6 years histology laboratory experience
• Histology Laboratory Analyst II: 6–8 years histology laboratory experience, including histochemistry (Special Stains)
• Senior Histology Laboratory Analyst: 8–10 years histology laboratory experience, including histochemistry (Special Stains)
• 1–3 years histochemistry (Special Stains) experience
• 1–3 years immunohistochemistry experience (3–5 years preferred or other advanced technical expertise)

Responsibilities

• Proficiently perform and document histological testing per standard operating procedures in compliance with cGxP guidelines and regulations
• Provide histology support for Quality, R&D, Clinical, Complaints, and Tissue Services departments
• Perform all phases of tissue preparation: paraffin and frozen technique, routine H&E staining, special stains (histochemistry), basic and advanced immunohistochemistry, microscopy, and image analysis
• Maintain, operate, qualify/validate histology equipment (microtome, cryostat, tissue processor, embedding units, stainer/coverslipper, balances, incubator, waterbath, microscope, etc.)
• Draft and update Standard Operating Procedures as needed
• Develop and transfer new techniques to support internal customers
• Train and mentor team members and peers in histological sample handling, histochemical/immunohistochemical technique, imaging, and analysis
• Act as final quality check on product prior to release; discretion to fail product and 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
• 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
• Prepare reagents and solutions for fixation and stain techniques; select appropriate materials and instrumentation from qualified suppliers
• Analyze stain results for accuracy and discern false results induced through the histological testing process
• Peer review sample preparation steps to ensure compliance with SOPs and cGxPs
• Develop in-depth knowledge of relevant scientific technologies to improve current techniques and support internal customer needs
• Conduct studies to improve techniques and introduce new methods
• Participate in and lead process improvement projects (e.g., Six-Sigma, Lean principles) in a time-sensitive, project-oriented manner
• Follow Laboratory Safety Standards, proper Biohazard & Chemical Waste Disposal, and comply with cGMP, GLP, and GDP
• Support audit activities and develop compliance awareness in team members
• Adhere to company work standards and Code of Conduct

Skills

• Histology, histochemistry (Special Stains), and immunohistochemistry (IHC) technique
• Immunohistochemistry technique (preferred)
• In-situ Hybridization (ISH) technique (preferred)
• Cell Biology and Tissue Structure knowledge
• Laboratory & Chemical safety, and Blood Borne Pathogens training
• Computer Skills: Word, Excel, PowerPoint, Outlook (Trackwise and SAP preferred)
• Organizational skills and 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
• 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
• Process improvement experience (e.g., Six-Sigma, Lean principles)
• Validation/qualification and method transfer experience (a plus)
• GDP training and experience in GMP, Good Clinical Practice, or GLP environments
• Familiarity with AATB, ISO, FDA, and USP regulations/guidelines and audits
• Essential skills: Excellence-focused, inquisitive, open and authentic, ownership, influence, courage, relationship-building, communication, critical thinking, customer orientation, decision-making

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off (subject to eligibility)
• Paid sick and safe time (subject to eligibility)
• Paid vacation time (subject to eligibility)
• Paid parental leave (subject to eligibility)
• Paid holidays annually (subject to eligibility)