Senior IT Applications Administrator

Work Schedule

Environmental Conditions

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 withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes 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:

• Bachelors 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.