Clinical Microbiology QA/QC & Compliance Specialist

Overview Indiana University Health is Indiana's most comprehensive health system, with 16 hospitals and more than 34,000 team members serving Hoosiers across the state. We're looking for team members who are inspired by challenging and meaningful work for the good of every patient. People who are compassionate and serve with a purpose. People who aspire to excellence every day. The laboratories of IU Health offer some of the most comprehensive laboratory services in Indiana! Open 24 hours a day, seven days a week, the laboratories perform more than 19 million tests a year. In addition to IU Health, laboratory testing services are provided to hospitals and physicians across the country. Shift: Full-time, days Location: IUHMG M-Pathology Lab (Indianapolis, IN) The Microbiology Technical Specialist is responsible for providing microbiological oversight and quality control for all the clinical microbiology testing in the pathology laboratory. 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 Microbiology Technical Specialist plays a proactive role in improving microbiological hygiene through the department, QA/QC review, techs training and competencies, assessing contamination risks, and driving continuous improvement initiatives. The successful candidate will have a strong background in clinical microbiology, QC / QA requirements, and knowledge of CLIA and CAP regulations. 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. Qualifications Bachelor's in medical technology, chemical, physical or biological science is required. Requires Qualification as CLIA Technical Consultant (TC) and Technical Supervisor (TS). Minimum 4 years experience in high complexity laboratory testing is required. Minimum 2 years experience in moderate complexity testing is required. Requires appropriate certification by ASCP, AMT, NCA or equivalent certification. Requires travel to locations within region on a regular basis. Travel to other regions, as needed. Requires extensive knowledge about computers and use of various software programs. Requires in-depth knowledge of standard operating procedures and testing techniques. Requires ability to troubleshoot equipment. Requires knowledge of state and federal regulations. Benefits 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! #J-18808-Ljbffr Asct