Quality Assurance Tester

Quality Assurance Tester

Zolon PCS is seeking a Quality Assurance Tester. This program will replace multiple decentralized and legacy quality management environments with a single, enterprise-wide platform that supports quality, compliance, training, audits, risk management, equipment management, supplier management, and corrective action processes across FDA Centers and Offices. The solution will support FDA organizations, including the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Human Food Program (HFP), Office of the Chief Scientist (OCS), Office of Inspections and Investigations (OII), and other FDA quality organizations.

Job Description:

• Develop, execute, and maintain functional, regression, integration, system, end-to-end, and user acceptance testing (UAT) activities for ComplianceQuest, Salesforce GovCloud, and integrated enterprise applications.
• Create and maintain test plans, test cases, test scripts, test data, traceability matrices, and testing documentation to ensure complete coverage of business and technical requirements.
• Collect and manage testing evidence, document test results, track defects, validate defect resolution, and support release readiness reviews.
• Support Computer System Validation (CSV), verification and validation (V&V), and change-control activities to ensure compliance with FDA, GxP, and regulated-system requirements.
• Validate system configurations, workflows, forms, reports, dashboards, integrations, and automation capabilities to ensure quality, performance, and compliance objectives are achieved.
• Collaborate with developers, architects, business analysts, quality teams, and customer stakeholders to validate requirements, define acceptance criteria, and ensure successful solution delivery.
• Execute integration and interface testing across cloud platforms, APIs, third-party applications, and enterprise systems to ensure interoperability and operational readiness.
• Prepare audit-ready validation artifacts, testing evidence, compliance documentation, and quality records supporting regulatory inspections and organizational audits.
• Provide subject matter expertise for proposal development, technical solutioning, customer demonstrations, oral presentations, technical exchanges, and capability briefings.
• Contribute lessons learned, best practices, reusable testing assets, and continuous improvement initiatives while supporting organizational growth and expansion of ComplianceQuest, Salesforce GovCloud, and Quality Management service offerings.

Requirements:

• Minimum 5 years of Salesforce application testing experience.
• Experience supporting Computer System Validation (CSV) activities.
• Experience creating validation protocols and traceability matrices.
• Experience executing system, integration, regression, and user acceptance testing.
• Experience documenting test evidence for audit purposes.
• Experience supporting regulated systems preferred.
• Experience supporting deployment readiness activities preferred.
• Bachelor's degree desired.
• Prior FDA experience desired.
• Certified Scrum Master (CSM) or Agile Certification desired

Clearance: Ability to obtain Public Trust tier 2

Location: White Oak, Maryland (Hybrid)