Technical Laboratory Specialist

Indiana University Health System • Indianapolis, IN

1d • Onsite

About The Position

Indiana University Health is Indiana’s most comprehensive health system, with 16 hospitals and more than 34,000 team members. Its laboratories offer extensive services, performing over 19 million tests annually for IU Health and other healthcare providers nationwide. The Microbiology Technical Specialist is responsible for providing microbiological oversight and quality control for all clinical microbiology testing within the pathology laboratory. This role involves collaboration 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. The specialist is expected to proactively improve microbiological hygiene, conduct QA/QC reviews, train technicians, assess contamination risks, and drive continuous improvement initiatives. A strong background in clinical microbiology, QC/QA requirements, and knowledge of CLIA and CAP regulations is essential for this position.

Requirements

• Bachelor's in medical technology, chemical, physical or biological science.
• Qualification as CLIA Technical Consultant (TC).
• Qualification as CLIA Technical Supervisor (TS).
• Minimum 4 years experience in high complexity laboratory testing.
• Minimum 2 years experience in moderate complexity testing.
• Appropriate certification by ASCP, AMT, NCA or equivalent certification.
• Requires travel to locations within region on a regular basis.
• Requires travel to other regions, as needed.
• Extensive knowledge about computers and use of various software programs.
• In-depth knowledge of standard operating procedures and testing techniques.
• Ability to troubleshoot equipment.
• Knowledge of state and federal regulations.

Responsibilities

• Perform special quality assurance projects/functions as defined by the facility's CLIA Director(s), pathology laboratory management, or administration.
• Collaborate with team leads and functional staff on technical validations.
• Provide quality assurance in accordance with GLP and GDP standards.
• Prepare and present QA reports to hospital management.
• Make operational and training improvements.
• Manage the technical process qualification program and schedule qualifications for lab personnel.
• Collaborate with Supervisors and team leads to actively support the review and investigation process for complaints and incidents in the microbiology lab.
• Develop and refine strategies and methodologies for microbiological testing and cleaning 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 Office of Compliance, Accreditation and Quality (OCAQ) teams to monitor and audit microbiology lab operations and processes, supporting the technical team needs.
• Support clinical microbiologists in developing and maintaining a microbiological control strategy.
• 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 and CAP requirements.
• Monitor contamination and initiate control measures to minimize risk.
• 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 microbiology processes, test methods, and equipment maintenance.
• Maintain proficiency testing, comparison of test results, personnel competency assessment, complaint investigation, and quality records.
• Creating and maintaining a digital regulatory crosswalk.
• Identify key microbial technologies and oversee projects from initiation to completion.
• 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.

Benefits

• Increased pay scale for bedside nurses.
• 401(K) retirement savings with employer match.
• Tuition reimbursement.
• Student loan forgiveness - Government program that may allow qualifying participants to have the remainder of their student loan balance forgiven (after a set amount of time and specific qualifications have been met).
• Employee Assistance Program – Counseling at no cost to you.
• Healthy Results - Participation in our team member wellness programs award points that contribute toward a biweekly financial incentive in your paycheck! The more you participate, the more you earn!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees