Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Senior Application Administrator is responsible for administering, configuring, validating, and supporting laboratory middleware, LIS applications, and instrument interfaces within a regulated GxP environment. This role ensures reliable instrument-to-LIS integrations, data integrity, regulatory compliance, and appropriate system lifecycle documentation. The position works closely with Laboratory Operations, Quality Assurance, Validation, and IT teams. *Must be legally authorized to work in the United States without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screening(where applicable) *Greater Cincinnati/Northern KY location required, Relocation assistance is not provided. Purpose: • Administer and support laboratory middleware, LIS applications, and instrument interfaces. • Configure instrument connections, test/code mappings, routing rules, communication parameters, and application settings. • Support onboarding and implementation of new instruments, analyzers, assays, and laboratory interfaces. • Manage configurations across Development, Test, Validation, and Production environments. • Troubleshoot interface, connectivity, mapping, transmission, and data integrity issues. • Execute Computer System Validation (CSV) activities, including IQ, OQ, and PQ. • Develop and execute validation protocols, test scripts, traceability documentation, and validation evidence. • Perform end-to-end testing from instrument processing through middleware and LIS reporting. • Review logs, audit trails, interface transactions, and reports to verify data integrity. • Support change controls, risk assessments, system upgrades, configuration changes, and production deployments. • Maintain compliance with 21 CFR Part 11, GxP, GDP, ALCOA+, and company quality procedures. • Maintain audit-ready documentation and support internal and regulatory inspections. • Collaborate with Laboratory Operations, QA, Validation, and IT teams and provide technical guidance to junior administrators. Education and Experience: • Bachelor's degree in IT, Computer Science, Engineering, Clinical Laboratory Science, Medical Technology, or a related field; equivalent experience may be considered. • 5+ years of experience supporting regulated laboratory, healthcare, clinical, or manufacturing applications. • 3+ years of experience with laboratory instruments, middleware, LIS, or medical device integrations. • Experience with GxP environments, CSV, IQ/OQ/PQ, change control, validation documentation, and audit support. • Knowledge of TCP/IP, serial communications, interface troubleshooting, and configuration management. Preferred Qualifications: • Experience with Instrument Manager or comparable laboratory middleware. • Knowledge of HL7, ASTM, GAMP 5, laboratory workflows, and quality control systems. • Experience with audit trails, data integrity assessments, assay validation, and reportable ranges. • Experience in clinical laboratories, pharmaceutical, biotechnology, CRO, or medical device environments. Regulatory Knowledge: 21 CFR Part 11 • GxP • GCP • GLP • GDP • CSV • ALCOA+ • Change Control • CAPA • Deviation Management Key Competencies: Validation & Compliance • Data Integrity • Technical Troubleshooting • Root Cause Analysis • Documentation • Cross-Functional Collaboration • Project Coordination • Audit Readiness Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • For Labs-based staff, exposure to biological fluids with potential exposure to infectious organisms. • For Labs-based staff, personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions. • Occasional travel. Physical Requirements: • Frequently stationary for 6-8 hours per day. • Repetitive hand movement of both hands. • Frequent mobility required. • Occasional crouching, stooping, bending and twisting. • Light to moderate lifting and carrying up to 15-20 lbs. • Ability to use a variety of computer software. • Ability to communicate information and ideas effectively, with the ability to listen to, and understand, information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Ability to multitask and perform under stress. • Regular and consistent attendance.