Technical Laboratory Specialist - Donor Screening Path Lab

Overview The IUH Donor Screening Laboratory (DSL) and Immunology and Serology Laboratory provide innovative, exceptional laboratory testing to meet the unique needs of the blood and tissue bank industry. The 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 and Immunology and Serology Laboratories in the Department of Pathology and Lab Services (Indianapolis). It is a salaried position for Mon-Fri day shift, with occasional rotation onto other shifts for training or technical duties. The Technical Specialist provides technical oversight and quality control for serology, NAT, and microbiology testing in the DSL, collaborating with medical directors, lab staff, and compliance teams to ensure aseptic techniques, microbiological control, and regulatory compliance. The role involves improving lab practices, training, document control, contamination risk assessment, and continuous improvement initiatives. The ideal candidate will have a strong background in serology and immunology testing automation, QC/QA, and knowledge of CLIA/CAP and FDA regulations. Responsibilities include: Performing quality assurance projects as defined by management or regulatory bodies. Collaborating on technical validations with division leads. Providing QA in accordance with GLP and GDP standards, and preparing QA reports. Implementing operational and training improvements. Managing the technical process qualification program and scheduling qualifications. Supporting investigation and review processes for complaints and incidents. Developing strategies for future testing and validations. Establishing and monitoring quality control procedures and environmental monitoring programs. Ensuring consistent QA guidelines in sample handling, analysis, and data reduction. Collaborating with auditors and regulatory inspectors to audit operations and quality systems. Developing microbiological control strategies. Identifying deviations, initiating corrective actions, and recommending improvements. Ensuring compliance with CLIA, CAP, and FDA requirements. Investigating non-conformances, corrective actions, and out-of-specification results. Reviewing and approving QC/QA documents, SOPs, and WIs. Assisting with personnel documentation, training, and procedure updates. Authoring and reviewing SOPs, protocols, and reports related to serology, immunology, and microbiology. Working with LIS to implement changes. Maintaining proficiency testing, competency assessments, and quality records. Conducting QA training for staff on regulations, inspections, and SOPs. Staying updated on laboratory developments through literature review and professional participation. Qualifications: BS or MS in medical technology, chemical, biochemical, or biological sciences. Meets CLIA Technical Supervisor (TS) qualification as per 42 CFR 493.1411. 2-4 years' experience in high complexity laboratory testing. Strong knowledge of FDA and CLIA regulations related to donor screening and serology. Certification by ASCP, AMT, NCA, or equivalent. Extensive computer and software skills. In-depth knowledge of SOPs and testing techniques. Ability to troubleshoot equipment with vendors and manufacturers. We offer: Increased pay scale for bedside nurses 401(K) with employer match Tuition reimbursement Student loan forgiveness programs Employee Assistance Program Wellness incentives through Healthy Results We are an equal opportunity employer valuing diversity and inclusion. Reasonable accommodations are provided for applicants with disabilities. Contact us to request accommodation. Indiana University Health is Indiana's most comprehensive health system, with 16 hospitals and nearly 40,000 team members serving Hoosiers across the state. Our partnership with the Indiana University School...

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