Associate Quality Analyst

Job Description

Job Description

Job Title: Associate Quality Analyst – Histology Analyst II Job Description

The Associate Quality Analyst (Histology Analyst II) performs and documents complex histological testing in support of Quality, R&D, Clinical, Complaints, and Tissue Services functions. This role covers all phases of tissue preparation for paraffin and frozen techniques, including routine H&E staining, special stains (histochemistry), immunohistochemistry, microscopy, and image analysis. The analyst serves as a key quality gate for product release, maintains and qualifies histology equipment, updates documentation, supports audits and inspections, and trains peers and technicians. This position offers opportunities to learn and develop advanced techniques such as in-situ hybridization, electron microscopy, bone histology, method and process validation, and Lean/Six Sigma principles.

• Act as the final quality check on products prior to release by proficiently performing histology analysis and evaluating stain results to determine whether findings are due to histological processing or production processes.
• Exercise discretion to fail product when appropriate and initiate, report, and investigate out-of-specification (OOS) results through the Quality Management System.
• Evaluate R&D, clinical, donor, and control tissue samples as requested, ensuring accurate and timely histological assessment.
• Collaborate with Medical Directors, scientists, and cross-functional teams to examine product tissue, donor tissue, clinical samples, and R&D study samples.
• Apply knowledge of gross anatomy and study objectives to dissect representative tissue samples and select appropriate stains for histology testing and analysis.
• Proficiently perform histology testing for QC product release samples, clinical complaint cases, donor samples, R&D, and engineering studies, including decalcification, rehydration, grossing, fixation, embedding, microtomy, routine staining, special stains (histochemistry), and immunohistochemistry.
• Conduct peer review of histology sample preparation steps to verify compliance with standard operating procedures and current GxP requirements.
• Develop in-depth knowledge of relevant scientific technologies to enhance current histological techniques and support evolving needs of internal customers.
• Draft, revise, and update Standard Operating Procedures and related controlled documents to reflect current practices and regulatory expectations.
• Participate in the training and development of technicians and peers in histological sample handling, histochemical and immunohistochemical techniques, imaging, and analysis.
• Actively support and adhere to the Quality System by diligently participating in compliance-related activities and following company work standards and Code of Conduct.
• Prepare reagents and solutions for fixation and staining techniques, and select appropriate materials and instrumentation from qualified suppliers.
• Operate, maintain, and qualify or validate standard laboratory and histology equipment such as microtomes, cryostats, tissue processors, embedding units, stainers and coverslippers, balances, incubators, water baths, microscopes, and related instruments.
• Follow laboratory safety standards, including proper biohazard and chemical waste disposal, and comply with current Good Laboratory Practices and Good Documentation Practices.
• Understand and act on departmental and project objectives, manage assigned project activities in a time-sensitive manner, and contribute to process improvement initiatives.
• Support validation and qualification activities for histology processes, methods, and equipment, including participation in data integrity risk assessments and system classifications.
• Contribute to histology automation and process improvement efforts, applying Lean, Six Sigma, or other continuous improvement methodologies where appropriate.
• Support audits and inspections by providing documentation, explaining histology processes, and demonstrating compliance with applicable regulations and standards.
• Use Laboratory Information Management Systems (LIMS) for sample tracking, data entry, and results reporting, and support LIMS development and optimization as needed.
• Perform microscope slide analysis and digital imaging, including image capture, management, and quantitative or qualitative image analysis.
• Participate in document updates and change control processes to ensure controlled and traceable implementation of procedural and system changes.
• Demonstrate leadership by taking ownership of assigned tasks, mentoring less experienced staff, and contributing to a culture of quality, safety, and continuous improvement.

• Bachelor’s degree in Biology or a related scientific discipline, or equivalent relevant laboratory experience.
• 6–8 years of histology laboratory experience, including routine and advanced histology techniques.
• 4–6 years of hands-on experience performing tissue preparation, including fixation, embedding, microtomy, staining, and specimen processing.
• Demonstrated experience with histochemistry (special stains) in a histology laboratory setting.
• 1–3 years of immunohistochemistry (IHC) experience, including staining and interpretation.
• Strong knowledge of tissue structure, cell biology, and gross anatomy applied to histological evaluation.
• Experience working in regulated laboratory environments such as GMP, GLP, and/or GCP settings.
• Proficiency in microscopy and image analysis for the evaluation of histological samples.
• Experience with microscope slide analysis and digital imaging and analysis workflows.
• Familiarity with histology automation and process improvement within a laboratory environment.
• Experience with equipment validations and qualifications for histology and laboratory instruments.
• Experience performing data integrity risk assessments and system classifications for laboratory systems.
• Ability to follow and interpret Standard Operating Procedures and work instructions with strong attention to detail.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Strong written and verbal communication skills for documentation, reporting, and cross-functional collaboration.
• Ability to work effectively in a time-sensitive, project-driven environment and manage multiple priorities.
• Demonstrated adherence to Good Laboratory Practices, Good Documentation Practices, and laboratory safety standards.
• Experience with Laboratory Information Management Systems (LIMS) for sample and data management.

• Technical certification such as HT, HTL, QIHC, or a related histology certification (preferred).
• Experience with advanced immunohistochemistry techniques and optimization of IHC protocols.
• Experience with method and process validation activities in a regulated laboratory environment.
• Exposure to or experience with Lean, Six Sigma, or other continuous improvement methodologies for process improvement.
• Experience supporting internal and external audits and inspections.
• Familiarity with AATB, ISO, FDA, and USP regulations and guidance relevant to tissue and laboratory practices.
• Experience with digital imaging systems, including acquisition, storage, and analysis of histological images.
• Technical writing experience, including authoring or revising SOPs, reports, and validation documentation.
• Demonstrated leadership skills, including mentoring, training, or leading aspects of laboratory projects.
• Experience with document updates and change control processes within a controlled quality system.
• Strong problem-solving skills with the ability to analyze histological findings and identify root causes related to process or product.
• Ability to collaborate effectively with cross-functional teams, including Quality, R&D, Clinical, Complaints, and Tissue Services.

This role is based in a regulated laboratory environment that operates under GMP, GLP, and GCP principles and complies with applicable quality and safety standards. The work involves routine handling of biological tissues and chemicals, requiring strict adherence to laboratory safety procedures, biohazard and chemical waste disposal protocols, and Good Laboratory and Good Documentation Practices. The position is highly hands-on and bench-focused, with extensive use of histology and laboratory equipment such as microtomes, cryostats, tissue processors, embedding units, stainers and coverslippers, balances, incubators, water baths, microscopes, and digital imaging systems. Work is typically performed during standard laboratory hours, with expectations to meet project timelines and support time-sensitive quality and clinical activities. The environment emphasizes collaboration with Quality, R&D, Clinical, Complaints, and Tissue Services teams, and encourages continuous learning, cross-training, and professional development in advanced histology techniques, process improvement, and quality systems. Appropriate laboratory attire, including personal protective equipment, is required to ensure safety and compliance.

This is a Contract position based out of Branchburg, NJ.

The pay range for this position is $27.00 - $31.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Branchburg,NJ.

This position is anticipated to close on Aug 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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