Senior IT Applications Administrator

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.