Nashville, TN 37203 | Contract
Zycron has a great opportunity for a Validation Specialist with our health care client in Nashville, TN. This is a junior to mid-level person. The Validation Specialist is responsible for supporting the validation strategy and policies of clinical systems and applications. This is a contract to hire position. No CTC and no visa sponsorship is available.
- Participate on computerized system validation and implementation project teams.
- Author computer system validation documentation ensuring compliance with applicable regulations.
- Ensure continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies.
- Authoring validation/qualification deliverables including but not limited to risk/impact assessments, validation plans, design specifications, requirements traceability, and validation summary reports.
- Assist in the development of detailed requirements for each new validated system.
- Assist with developing test strategies and defining test data (i.e. design the approach for testing each requirement).
- Assist with authoring validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ).
- Coordinate and oversee execution of validation and verification testing protocols/scripts for software under development and/or commercial off the shelf software products including identification and resolution of non-conformances/deviations.
- Assist with the evaluation of changes to the validated state of systems and determine validation requirements for applications through change control procedures and participate in the planning and implementation of changes; ensure completion of validation documentation before changes are implemented.
- Prior experience writing technical documents for validation as required by the FDA.
- Familiarity with 21 CFR Part 11, e-signature, and FDA records.
- Experience validating that clinical systems are performing as designed.
- Familiar with the following or similar: CTMS system, Argus, Safety Reporting, and systems used in Clinical Research (CRO applications).
- ValGenesis or similar validation lifecycle management system.
- Experience working in a manual QA type role with the developers for unit testing (writing and executing test scripts).
If you are interested in learning more about this opportunity, please contact Cindy Raleigh at email@example.com or 702-645-9860.