Technical Laboratory Specialist - Donor Screening Path Lab

The IUH Donor Screening Laboratory (DSL) and Immunology and Serology Laboratory provide innovative, exceptional laboratory testing to meet the unique testing needs of the blood and tissue bank industry. Donor Screening Lab is CLIA certified, CAP accredited, and FDA registered for screening human cells, tissues, and cellular and tissue - based products (HCR/Ps).

This position is for a Technical Specialist in the Donor Screening laboratory and Immunology and Serology Laboratory in the Department of Pathology and Lab services (Indianapolis). It is a salaried position for Mon-Fri day shift. Occasional rotation onto other shifts for training purposes or other technical duties may be required. The Technical Specialist is responsible for providing technical oversight and quality control for all the serology, NAT and microbiology testing in the DSL. This role involves collaborating with medical director(s), lab staff and the Office of Compliance, Accreditation and Quality (OCAQ) teams to ensure aseptic techniques, microbiological control strategies, and regulatory compliance are maintained throughout the testing process. The DSL Technical Specialist plays a proactive role in improving good lab practice (GLP), good document practice (GDP), QA/QC review, techs training and competencies, document control, assessing contamination risks, and continuous improvement initiatives. The successful candidate will have a strong background in serology and immunology testing automation, QC / QA requirements, and knowledge of CLIA/CAP and FDA regulations.

 

• Perform special quality assurance projects/functions as defined by the facility's CLIA Director(s), pathology laboratory management, or administration.
• Collaborate with Serology/ Microbiology divisions’ leads and functional staff on technical validations.
• Provide quality assurance in accordance with GLP and GDP standards, prepare and present QA reports to department management.
• Make operational and training improvements.
• Manage the technical process qualification program and schedule qualifications for lab personnel.
• Collaborate with outreach managers and lab teams to actively support the review and investigation process for complaints and incidents.
• Develop and refine strategies and methodologies for future testing and test verifications and validations.
• Establish quality control procedures, monitor remedial actions, and oversee the environmental monitoring program, personnel monitoring, trending, and analysis.
• Maintain consistent quality assurance guidelines throughout sample handling, analytical, and data reduction processes.
• Collaborate with OCAQ team, Internal auditor(s) and external assessor(s) like FDA inspectors to audit DSL operations, quality and processes.
• Developing and maintaining a microbiological control strategy within testing areas.
• Identify deviations from the quality system or test procedures, initiate actions to prevent or minimize such departures, and make recommendations for improvements.
• Ensure compliance with CLIA, CAP and FDA requirements.
• Assist in investigations of non-conformances, corrective actions, out-of-specification investigations, and preventive action investigations. Monitor errors in reported results and document complaints, investigations, corrective actions, and resolutions.
• Review and approve QC/QA documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs).
• Assist in personnel documentation, training, SharePoint design, and procedure/document updates.
• Author, and review SOPs, protocols, and reports related to serology, immunology (including autoimmune diseases testing) and various other microbiology processes, test methods, and equipment maintenance.
• Work with laboratory information services (LIS) to implement required changes and/or additions.
• Maintain proficiency testing, comparison of test results, personnel competency assessment, complaint investigation, and quality records.
• Conduct periodic quality assurance training for staff, focusing on regulations, monitoring, inspections, SOPs, and other relevant areas.
• Stay updated on laboratory developments by reviewing current literature, attending educational programs, and actively participating in professional organizations.

 

QUALIFICATIONS

• BS or MS in medical technology, chemical, biochemical or biological science is required.
• Meets the qualification as CLIA Technical Supervisor (TS) described in 42 CFR 493.1411.
• Minimum 2-4 years’ experience in high complexity laboratory testing is required.
• Strong knowledge of FDA and CLIA regulations related to donor screening and clinical serology.
• Requires appropriate certification by ASCP, AMT, NCA or equivalent certification.
• Requires extensive kn