Work Schedule

Environmental Conditions

Job Description

SUMMARY

The Senior Application Administrator is responsible for the administration, configuration, validation, and lifecycle management of laboratory middleware and instrument interfaces within a regulated GxP environment. This role serves as the technical owner for instrument-to-LIS integrations, ensuring compliance with 21 CFR Part 11, Good Documentation Practices (GDP), Computer System Validation (CSV) requirements, and company quality standards. The position partners closely with Laboratory Operations, Quality Assurance, Validation, and Information Technology teams to implement, validate, maintain, and support medical device interfaces and associated workflows. Responsibilities include change control execution, configuration management, IQ/OQ/PQ activities, end-to-end testing, data integrity verification, audit support, and production support of laboratory applications.

ESSENTIAL RESPONSIBILITIES

Application Administration & Interface Management - Administer and support laboratory middleware applications, including Instrument Manager and associated laboratory information systems (LIS). - Configure and maintain instrument interfaces, routing rules, test mappings, code mappings, and communication parameters. - Manage application configurations across Development, Test, Validation, and Production environments. - Support onboarding of new instruments, analyzers, assays, and third-party laboratory interfaces. - Configure and maintain TCP/IP, serial, file-based, and other interface communication methods. - Perform troubleshooting and root cause analysis for interface failures, transmission issues, mapping discrepancies, and data integrity concerns. Computer System Validation (CSV) - Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. - Author, review, and execute validation protocols, test scripts, validation plans, and validation summaries. - Maintain objective evidence packages, including screenshots, logs, reports, and validation artifacts. - Ensure traceability between requirements, configurations, test cases, and validation results. - Support risk-based validation methodologies and lifecycle documentation practices. End-to-End Testing & Data Integrity - Lead end-to-end testing activities for new and modified instrument interfaces. - Validate complete workflow processing from sample receipt through instrument processing, middleware routing, result transmission, and LIS reporting. - Verify accuracy of test mappings, units, ranges, routing logic, and reportable results. - Review system logs, audit trails, comparison reports, and interface transactions to ensure data integrity. - Investigate and resolve discrepancies between instrument output, middleware data, and LIS results. Change Control & Compliance - Participate in change control activities, impact assessments, and validation planning. - Determine validation scope based on system modifications and regulatory requirements. - Support implementation of configuration-only changes, rule modifications, upgrades, and new interface deployments. - Ensure compliance with 21 CFR Part 11, GxP requirements, data integrity principles (ALCOA+), and company quality procedures. - Maintain audit-ready documentation and support internal, client, and regulatory inspections. Cross-Functional Collaboration - Partner with Laboratory Operations, Quality Assurance, Validation Specialists, CAP Directors, and Information Technology teams. - Facilitate interface implementation projects and validation activities across multiple laboratory locations. - Coordinate test scheduling, readiness assessments, and deployment activities. - Provide technical guidance and mentorship to junior administrators and support personnel. Documentation & Quality Systems - Create, review, and maintain controlled documentation, including: Test Maps, Interface Specifications, Validation Documentation, Change Control Records, Configuration Records, Operational Procedures. - Ensure documentation complies with electronic records and electronic signature requirements. - Maintain complete traceability and documentation retention in accordance with quality system requirements.

REQUIRED QUALIFICATIONS

Education - Bachelor's degree in Information Technology, Computer Science, Engineering, Medical Technology, Clinical Laboratory Science, or related discipline. - Equivalent combination of education and relevant experience may be considered. Experience - 5+ years of experience administering regulated laboratory, healthcare, clinical, or manufacturing applications. - 3+ years of experience supporting medical device, instrument, middleware, or laboratory system integrations. - Experience working in GxP-regulated environments. - Experience executing or supporting CSV activities including IQ, OQ, and PQ. - Experience with change control, validation documentation, and audit support. Technical Skills - Laboratory Information Systems (LIS) and middleware platforms. - Instrument Manager or comparable middleware applications. - Medical device and laboratory instrument interfacing. - TCP/IP networking, serial communications, and interface troubleshooting. - Configuration management and controlled software deployment practices. - Validation documentation and testing methodologies. - Microsoft Office applications and electronic document management systems.

PREFERRED QUALIFICATIONS- Experience in clinical laboratory, central laboratory, pharmaceutical, biotechnology, CRO, or medical device environments. - Knowledge of HL7, ASTM, or other healthcare messaging standards. - Familiarity with GAMP 5 principles. - Experience supporting quality control systems and laboratory workflows. - Knowledge of laboratory assay validation and reportable range management. - Experience with audit trail review and data integrity assessments.

REGULATORY & COMPLIANCE KNOWLEDGE- 21 CFR Part 11 - Good Clinical Practice (GCP) - Good Laboratory Practice (GLP) - Good Documentation Practices (GDP) - Computer System Validation (CSV) - Change Control Processes - CAPA and Deviation Management - Data Integrity Principles (ALCOA+) KEY COMPETENCIES- Validation and compliance leadership - Data integrity and risk assessment - Technical troubleshooting and root cause analysis - Cross-functional communication - Documentation excellence - Attention to detail - Project coordination - Audit readiness - Problem solving and decision making SUCCESS MEASURES- Reliable and compliant operation of laboratory interfaces and applications. - Successful execution of validation activities with minimal findings. - Accurate and timely implementation of system changes. - Maintenance of audit ready documentation and objective evidence. - Effective collaboration with laboratory, quality, and IT stakeholders. - Consistent adherence to regulatory and quality requirements