RCI-ABBV-Histology Laboratory Analyst​/Equipment Validation & Qualification Specialist

Manager is particularly interested in a candidate with Histology and equipment validation experience in a GxP environment. If no specific histology experience, I would consider a candidate with experience in validating laboratory equipment in a GxP environment.

• We are hiring for Quality and Laboratory roles supporting a regulated histology lab environment.
• These roles require a blend of hands‑on lab expertise and quality assurance knowledge, including GMP compliance, validation, and documentation.

• Strong GMP / GxP experience (Mandatory – No Flexibility)
• Experience in regulated lab environment (Pharma/Biotech)
• Equipment Validation & Qualification
• Documentation & Change Control
• Quality Systems knowledge
• Exposure to CAPA / Deviations / OOS / OOT investigations, Root Cause Analysis, Data Integrity principles
• Bachelor’s Degree (Required) – Biology or related field
• PhD / MD candidates not ideal
• Local candidates strongly preferred
• Relocation will work
• Strong hands‑on histology expertise
• Leadership / mentoring experience
• Balanced lab + QA capability
• 10–20 years experience

• Histology automation
• Process improvement experience
• LIMS implementation/integration
• Data integrity risk assessments
• Cross‑functional QA exposure
• Leadership / team coordination

• GMPs/GXPs,
• Histology automation and process improvements
• Equipment validations/qualifications
• Microscope slide analysis, Digital imaging and analysis
• Document updates and change control
• LIMS (Laboratory Information Management System) development and operation

• The Senior Histology Analyst is responsible for proficiently performing and documenting histological testing per standard operating procedures in compliance with cGxP guidelines and regulations.
• 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), basic and advanced immunohistochemistry, microscopy and image analysis.
• The Senior Histology Analyst is also responsible for data review and test result reporting/release, protocol development, process improvement studies, and collaborating with cross functional collegues to develop new/alternate techniques such as in‑situ hybridization, bone histology, and immunofluorescence.
• Additional responsibilities include:
  
  the maintenance, operation and qualification/validation of histology equipment; document revisions and change control; audit support; investigating abberant test results, nonconformances, corrective action/preventative actions; team metrics; training technicians/peers in histological sample handling, histochemical/immunohistochemical technique, digital imaging and analysis; and may be required to cover meetings for and support management.

• Acts as the final quality check on product prior to product release by proficiently performing Histology analysis. Discretion to fail product, report and investigate the OOS through the Quality Management system.
• A key responsibility includes data review of technical and analytical aspects of testing and making the final decision on product test acceptability.
• Apply an understanding of gross anatomy and study purpose to determine, dissect, and orient representative samples for histology testing and analysis.
• Collaboration with Medical Directors and Scientists in testing and evaluation of Quality control test samples, Donor tissue, Complaints, and R&D study samples.
• Understand and act on departmental and project objectives and metrics.
• Lead process…