[Hiring] Quality Assurance Analyst @Emmes Group

Role Description

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).

• 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.
• Evaluates software and associated documentation using a risk-based model and ensures compliance with Good Automated Manufacturing Practice (GAMP) 5, FDA regulations, and applicable international standards.
• Supports the preparation of milestone reports, quality assessments, and presentations for internal teams, leadership, and end-user representatives.
• Maintains oversight of quality activities throughout the SDLC, conducting formal and informal reviews at predetermined checkpoints.
• Participates in quality and validation checkpoints across the SDLC, ensuring validation evidence is complete, accurate, and compliant with regulatory 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.

Qualifications

• 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.

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.

Benefits

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment