Quality Assurance

Quality Assurance Specialist III / Senior Histology AnalystThe Quality Assurance Specialist III / Senior Histology Analyst performs and documents complex histological testing in compliance with cGxP guidelines and regulations. This role provides advanced histology support to Quality, R&D, Clinical, Complaints, and Tissue Services functions, covering all phases of tissue preparation, staining, microscopy, and image analysis. The position also leads data review and test result release, protocol development, process improvement initiatives, equipment qualification and validation, and supports audits and quality systems within a highly regulated laboratory environment.Responsibilities:Perform and document histological testing in accordance with standard operating procedures and cGxP guidelines.Support Quality, R&D, Clinical, Complaints, and Tissue Services teams with expert histology services and guidance.Execute all phases of tissue preparation, including fixation, embedding, microtomy, and both paraffin and frozen section techniques.Perform routine H&E (Hematoxylin & Eosin) staining and a wide range of special stains (histochemistry).Conduct basic and advanced immunohistochemistry (IHC) procedures and interpret results.Utilize microscopy and digital image analysis to evaluate tissue sections and document findings.Review generated data for accuracy and completeness and make final decisions regarding test acceptability and product release.Develop, optimize, and implement new protocols and methods, including in-situ hybridization, bone histology, and immunofluorescence, in collaboration with cross-functional colleagues.Lead and participate in process improvement studies, including histology automation and continuous improvement initiatives.Operate, maintain, qualify, and validate histology and laboratory equipment to ensure reliable performance.Prepare and execute equipment validation and qualification protocols in alignment with regulatory and quality requirements.Update, revise, and implement standard operating procedures and controlled documents, ensuring robust document control and change control practices.Support and participate in internal and external audits, inspections, and compliance initiatives related to histology and quality systems.Investigate aberrant test results, nonconformances, and laboratory issues using strong root-cause analysis and laboratory investigation practices.Contribute to corrective and preventive actions (CAPA) and follow-through on implementation and effectiveness checks.Track and contribute to team metrics and performance indicators related to laboratory operations and quality.Train, mentor, and develop technicians and peers in histological sample handling, histochemistry, immunohistochemistry, digital imaging, and analysis.Provide leadership support to the laboratory team and, when needed, represent the department in meetings and support management activities.Participate in LIMS (Laboratory Information Management System) development and operation to ensure accurate sample tracking and data integrity.Perform data integrity risk assessments and system classifications for laboratory systems and processes.Ensure work complies with GMP, GLP, GCP, and other relevant regulatory and quality standards.Collaborate with cross-functional teams to transfer methods, support validation activities, and align on best practices.Contribute to continuous improvement of laboratory workflows, throughput, and automation while maintaining high quality standards.Essential Skills:Bachelor's degree in Biology or a related science, or equivalent work experience.6–8 years of histology laboratory experience, including hands-on histochemistry (special stains).1–3 years of immunohistochemistry (IHC) experience, with the ability to independently perform and troubleshoot IHC assays.Extensive experience with tissue preparation, fixation, embedding, microtomy, and routine and special staining procedures.Demonstrated proficiency in histochemistry (special stains) and interpretation of staining quality.Experience with microscopy and digital image analysis for evaluation of tissue sections.Experience reviewing laboratory data and making final decisions on test acceptability and product release.Strong laboratory investigation skills, including root-cause analysis of test failures, deviations, and nonconformances.Experience developing, revising, and implementing standard operating procedures and controlled documents.Experience operating, qualifying, and validating laboratory and histology equipment.Experience working in GMP, GLP, GCP, or similar regulated laboratory environments.Experience supporting audits, inspections, and compliance initiatives within a quality system framework.Experience with histology automation and process improvements in a laboratory setting.Experience with equipment validations and qualifications in a regulated environment.Experience with microscope slide evaluation, digital imaging, and image analysis tools.Demonstrated leadership skills, including the ability to guide, mentor, and train laboratory staff.Experience with document updates and change control processes within a quality management system.Experience with LIMS (Laboratory Information Management System) development and operation.Experience performing data integrity risk assessments and system classifications for laboratory systems.Strong analytical skills with the ability to interpret complex data and identify trends or issues.Strong technical writing skills for clear documentation, protocols, reports, and investigations.Strong problem-solving skills with the ability to resolve technical and quality-related issues effectively.Additional Skills & Qualifications:Master's degree or higher in Biology or a related scientific discipline.Technical certification such as HT, HTL, QIHC, or a related certification.3–5 years of immunohistochemistry (IHC) experience or comparable advanced histology expertise beyond the minimum requirements.In-situ hybridization (ISH) experience, including method execution and interpretation.Immunofluorescence experience for advanced tissue analysis.Method transfer experience, including transferring assays between laboratories or sites.Validation and qualification expertise for methods, equipment, and systems.Lean Six Sigma or other continuous improvement experience and training.Experience with TrackWise and/or SAP or similar quality and enterprise systems.Familiarity with AATB, ISO, FDA, and USP regulations and guidance relevant to tissue and laboratory operations.Leadership experience supporting management functions and departmental initiatives.Experience contributing to team metrics, performance tracking, and reporting.Work Environment:This role operates in a regulated laboratory environment that follows GMP, GLP, GCP, and broader cGxP standards. You will work extensively with histology equipment, including tissue processors, embedding stations, microtomes, staining platforms, and microscopes, as well as digital imaging and analysis systems. The position involves regular use of a Laboratory Information Management System (LIMS) and other electronic quality and enterprise systems such as TrackWise and SAP or their equivalents. Work typically takes place in a controlled laboratory setting that requires adherence to standard laboratory safety practices and appropriate laboratory attire. The environment emphasizes quality, compliance, continuous improvement, and cross-functional collaboration, with opportunities to contribute to audits, process optimization, method development, and automation initiatives.Job Type & Location:This is a Contract position based out of Branchburg, NJ.Pay and Benefits:The pay range for this position is $45.00 - $50.00/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 & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace Type:This is a fully onsite position in Branchburg, NJ.Application Deadline:This position is anticipated to close on Aug 21,