Quality Assurance Analyst - Essex Management (Contingent Role)

OverviewQuality Assurance Analyst - Essex Management (Contingent Role)Location:US RemoteNotice to Candidates:Employment in this position is expressly contingent upon Essex Management's receipt of a contract award from the Federal Government.About Essex / Emmes GroupThis 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.Primary PurposeThe Quality Assurance (QA) Analyst provides technical and administrative support 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 enduser 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 enduser representatives.The QA Analyst supports the development and quality control of Computer Systems Validation (CSV) plans, applies riskbased 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.ResponsibilitiesProvide technical and administrative oversightof software development activities to ensure work products meet federal, programmatic, and user standards throughout the full SDLC. Review software deliverables and documentationfor accuracy, completeness, adherence to design specifications, and compliance with government requirements and quality standards. Evaluate computerized systems and associated documentationto ensure compliance with GAMP 5, FDA regulations, and applicable international standards. Support the development, review, and quality control of CSV plans , applying riskbased approaches across the system life cycle. Support risk assessmentsto ensure data integrity, system reliability, and alignment with regulatory expectations. Coordinate with Quality Assurance Managers, Project Managers, , and technical teamsto identify, track, and resolve issues to the satisfaction of end users and stakeholders. Support the monitoring of project progressagainst schedules and identify risks, deviations, or quality concerns requiring corrective action. Support the preparation of milestone reports, quality assessments, and presentationsfor internal teams, leadership, and enduser representatives. Conduct formal and informal reviewsat predetermined checkpoints throughout the SDLC, including design reviews, documentation reviews, test readiness reviews, and release reviews. Ensure consistent application of quality standardsacross requirements, design, development, testing, deployment, and maintenance activities. Support continuous improvement of quality processes , tools, and documentation practices within the program or project.Required Skills: Strong understanding of the SDLC, including Waterfall, Agile, and hybrid methodologies. Experience with software quality assurance practicesin government, federal contracting, or regulated industries. Knowledge of GAMP 5, FDA regulations (21 CFR Part 11), and international quality standardsrelated to computerized systems. Handson experience with CSVincluding developing, reviewing, or executing validation plans, test scripts, and traceability matrices. Ability to understand and apply riskbased approachesto 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 problemsolving skillswith the ability to identify quality issues, assess impact, and recommend corrective actions. Experience conducting formal and informal reviewsat 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 effectivelywith Project Managers, QA Managers, developers, testers, and enduser representatives. Excellent written and verbal communication skills, including the ability to prepare clear reports, quality assessments, and presentations. Detailoriented mindsetwith a strong commitment to accuracy, compliance, and documentation quality. Understanding of data integrity principlesand their application to regulated computerized systems. Ability to work independently and manage multiple tasksin a fastpaced, deadlinedriven environment.Qualifications2-5+ years of experiencein 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. Handson 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, riskbased validation approaches, and lifecycle documentation expectations.Why work at Emmes?At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through ourEmmes Carescommunity engagement program.We offer a competitive benefits package focused on the health and needs of our growing workforce, including:Flexible Approved Time OffTuition Reimbursement401k Retirement Plan Work From Home Anywhere in the USMaternal/Paternal LeaveCasual Dress Code & Work EnvironmentCONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - EmmesThe Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.#LI-Remote