Quality Assurance Analyst - Essex Management; Contingent

Overview

Quality Assurance Analyst - Essex Management (Contingent Role)
Location: US Remote
Notice to Candidates: Employment in this position is expressly contingent upon Essex Management’s receipt of a contract award from the Federal Government.

This position supports Essex, an Emmes Company, a biomedical informatics and health IT consultancy founded in 2009 and headquartered in Rockville, MD. Essex specializes in developing and managing complex health and biomedical information programs for federal agencies, academic research institutions, and private-sector clients.

Emmes Group is transforming the future of clinical research, advancing innovation in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. We are committed to improving patient outcomes through data, technology, and scientific excellence.

We are currently hiring for multiple Clinical Systems Business Analyst roles across two levels (Level I and Level II), with multiple positions available at each level.

The Quality Assurance (QA) Analyst provides technical and administrative support for software development activities supporting government GxP-regulated clinical systems. This role ensures that all software products, documentation, and processes meet federal standards, program requirements, and quality expectations throughout the full system development life cycle (SDLC).

The QA Analyst works closely with Quality Assurance Managers, Project Managers, technical teams, and end-user representatives to verify that deliverables are accurate, compliant, and aligned with user needs. This role evaluates software and associated documentation using a risk-based model and ensures computerized systems in regulated environments comply with Good Automated Manufacturing Practice (GAMP
5), FDA regulations, and applicable international standards. This role supports the preparation of milestone reports, quality assessments, and presentations for internal teams, leadership, and end-user representatives.

The QA Analyst supports the development and quality control of Computer Systems Validation (CSV) plans, applies risk-based approaches throughout the system life cycle, and conducts risk assessments to ensure data integrity, system reliability, and adherence to regulatory expectations. This role conducts periodic quality assessments, provides recommendations, and prepares summary reports outlining required corrective actions. The QA Analyst demonstrates experience applying GxP principles across the full system life cycle—including requirements definition, design qualification, development oversight, testing, deployment, and maintenance—to ensure that computerized systems consistently meet federal, FDA, and industry standards.

Throughout the SDLC, the QA Analyst maintains oversight of quality activities, conducts formal and informal reviews at predetermined checkpoints, and ensures that quality standards and traceability are consistently applied across requirements, design, development, testing, deployment, and maintenance. This role participates in quality and validation checkpoints across the SDLC, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities, ensuring that validation evidence is complete, accurate, and compliant with regulatory expectations.

• Provide technical and administrative oversight of software development activities to ensure work products meet federal, programmatic, and user standards throughout the full SDLC.
• Review software deliverables and documentation for accuracy, completeness, adherence to design specifications, and compliance with government requirements and quality standards.
• Evaluate computerized systems and associated documentation to ensure compliance with GAMP 5, FDA regulations, and applicable international standards.
• Support the development, review, and quality control of CSV plans
  , applying risk-based approaches across the system life cycle.
• Support risk assessments to ensure data integrity, system reliability, and alignment with regulatory expectations.
• Coordi…