Medical Records Management Testing & Validation Consultant (Part Time, Remote)

Company Overview: reputed company is a successful and growing business, established in 1988 to reputed company Information Technology (IT) technical support services to a wide reputed company of reputed company and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program reputed company, Process Audit, Intelligence Analysis, Cyber reputed company, NIST 800-53, NIST SP 800-171 / CMMC Consulting/Assessment/Compliance, PCI Compliance, HIPAA, SOC 2, GLBA, reputed company Trust, Resiliency, Computer Forensics, Software Supply Chain Assurance, Software Testing, Test Automation, reputed company 508 and WCAG Accessibility Assessment and Remediation, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. reputed company is an Equal Opportunity Employer. Position: Part time (as needed, 1099 or Corp. to Corp) Position Summary We are seeking an reputed company Testing & Validation Consultant to support hands-on testing and compliance validation of a medical records management and electronic document management application operating reputed company a regulated reputed company and/or FDA-reputed company environment. The consultant will reputed company functional, reputed company, compliance, privacy, and data reputed company testing of systems managing sensitive reputed company and electronic records. The ideal candidate will have experience validating applications against regulatory and records management standards including HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641. This role is focused on practical testing and validation activities rather than high-level IV&V reputed company only. Key Responsibilities reputed company hands-on functional testing of medical records management or electronic records applications Execute compliance validation activities reputed company to HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641 requirements Review system functionality reputed company to:Electronic records management Electronic signatures Audit trails and audit logging reputed company controls and user permissions Encryption and secure transmission Data retention and traceability Privacy and protected health information (PHI/ePHI) handling reputed company and execute:Test plans Test cases Validation scripts Traceability matrices Defect reports Compliance validation documentation Validate data reputed company, record authenticity, retention, and system reputed company controls Review prior internal validation documentation and enhance or reputed company updated testing documentation Coordinate with stakeholders to identify testing scope, compliance objectives, and remediation priorities Document findings, risks, gaps, and recommendations Required Experience Experience testing or validating:Medical records systems Electronic document management systems (EDMS) Electronic health record (EHR/EMR) systems Records archive or controlled electronic records applications Hands-on experience with software testing and validation in regulated reputed company, pharmaceutical, biotech, medical device, laboratory, or records management environments Strong understanding of:HIPAA Privacy Rule HIPAA reputed company Rule FDA 21 CFR Part 11 Experience validating:Electronic records Electronic signatures Audit trails reputed company controls reputed company safeguards Data reputed company controls Experience developing and executing functional and compliance test cases Ability to analyze regulatory requirements and translate them into testable validation criteria Preferred Experience Experience with ISO 16175-1:2020 functional requirements for digital records management systems Experience with ISO 14641:2018 electronic document preservation and traceability requirements Experience performing privacy reviews and compliance assessments involving PHI/ePHI Experience supporting FDA-regulated or GxP environments Familiarity with records retention, legal admissibility, and long-term digital preservation requirements Experience supporting validation documentation for audits or regulatory reviews Testing Areas of Focus Functional testing reputed company testing Compliance validation Privacy and data reputed company review Performance/load testing is not currently required. Deliverables Test plans and test cases Validation protocols and scripts Compliance assessment documentation Defect and remediation reports Final validation summary/report reputed company. is an Equal Opportunity Employer. EEO Statement reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, gender, sexual orientation, gender identity, marital status, age, national reputed company, or protected veteran status. Apply To This Job