17 hours ago
Remote, United StatesSenior
Responsibilities
- Review system requirements, validation documentation, and prior IQ/OQ/PQ documentation.
- Develop and/or execute validation plans, test cases, protocols, and test scripts.
- Perform functional software validation and verification testing.
- Validate data integrity, audit trails, access controls, authentication, and security-related functionality.
- Analyze CSV, JSON, and database datasets using queries, automated scanning, pattern matching, and exception analysis.
- Identify sensitive information and patterns, including PII, PHI, and other identifiers.
- Document test results, findings, supporting evidence, exceptions, remediation, and retesting.
- Support development of repeatable validation and testing methodologies and final validation/IV&V reports.
- Participate in client technical discussions and requirements clarification.
Requirements
- Experience with software validation, QA, IV&V, or computer system validation.
- Hands-on experience with functional software testing and IQ, OQ, and/or PQ protocols.
- Knowledge of FDA 21 CFR Part 11 and understanding of HIPAA, PII, PHI, privacy, and data integrity requirements.
- Experience with Python and/or SQL for data analysis, querying, or automated testing.
- Ability to work with CSV, JSON, databases, and large datasets.
- Experience with automated scanning, data querying, pattern or identifier detection, or sensitive-data discovery.
- Ability to document testing methodology, evidence, findings, and exceptions in a formal validation environment.
- Comfort working as a 1099 independent contractor on a part-time, project-based basis.
- Preferred experience in healthcare, pharmaceutical, life sciences, medical device, or another regulated industry.
- Preferred experience with de-identification, data masking, anonymization, PII/PHI detection, data classification, test automation, records management, electronic records systems, or security testing.
- Familiarity with ISO 16175-1 and/or ISO 14641.
Benefits
- Remote, part-time, short-term project-based consulting engagement.
- 1099 or Corp. to Corp. contract arrangement.
- Project duration is short-term and compensation is listed at $60-$100 per hour.
