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.
