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.

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.