Quality Assurance Analyst - Essex Management (Contingent Role)

Emmes Group•Rockville, MD

5d•Remote

About The Position

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, Food and Drug Administration (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.

Requirements

Strong understanding of the SDLC, including Waterfall, Agile, and hybrid methodologies.
Experience with software quality assurance practices in government, federal contracting, or regulated industries.
Knowledge of GAMP 5, FDA regulations (21 CFR Part 11), and international quality standards related to computerized systems.
Hands-on experience with CSV including developing, reviewing, or executing validation plans, test scripts, and traceability matrices.
Ability to understand and apply risk-based approaches to validation, testing, and quality assessments throughout the system life cycle.
Proficiency in reviewing technical documentation, including requirements, design specifications, test plans, test results, and user documentation.
Strong analytical and problem-solving skills with the ability to identify quality issues, assess impact, and recommend corrective actions.
Experience conducting formal and informal reviews at key SDLC checkpoints (design reviews, code reviews, test readiness reviews, release reviews).
Familiarity with quality management systems (QMS) and documentation control processes.
Ability to collaborate effectively with Project Managers, QA Managers, developers, testers, and end-user representatives.
Excellent written and verbal communication skills, including the ability to prepare clear reports, quality assessments, and presentations.
Detail-oriented mindset with a strong commitment to accuracy, compliance, and documentation quality.
Understanding of data integrity principles and their application to regulated computerized systems.
Ability to work independently and manage multiple tasks in a fast-paced, deadline-driven environment.
2–5+ years of experience in clinical software product quality assurance, test engineering, or validation within government, federal contracting, or regulated industries (e.g., life sciences, healthcare, clinical research).
Demonstrated experience applying GxP principles across the full system life cycle, including requirements definition, design qualification, development oversight, testing, deployment, and maintenance.
Hands-on experience with Computer Systems Validation (CSV) activities, including authoring, reviewing, or executing: Validation Plans (VP), User Requirements Specifications (URS), Functional and Design Specifications, Test Plans, Test Scripts, and Traceability Matrices, Validation Summary Reports (VSR).
Strong working knowledge of GAMP 5 guidance, risk-based validation approaches, and lifecycle documentation expectations.

Responsibilities

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.
Coordinate with Quality Assurance Managers, Project Managers, and technical teams to identify, track, and resolve issues to the satisfaction of end users and stakeholders.
Support the monitoring of project progress against schedules and identify risks, deviations, or quality concerns requiring corrective action.
Support the preparation of milestone reports, quality assessments, and presentations for internal teams, leadership, and end-user representatives.
Conduct formal and informal reviews at predetermined checkpoints throughout the SDLC, including design reviews, documentation reviews, test readiness reviews, and release reviews.
Ensure consistent application of quality standards across requirements, design, development, testing, deployment, and maintenance activities.
Support continuous improvement of quality processes, tools, and documentation practices within the program or project.