JT628 - QUALITY APPLICATIONS SPECIALISTS
Quality Consulting Group Ver todas las vacantes
- Villalba, PR
- Temporal
- Tiempo completo
- Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
- Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
- Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
- Bachelor’s degree in related area
- 3+ years of relevant experience
- Lean Six Sigma Green Belt Certification
- Experience working with systems including Microsoft Office (Excel, Word, Outlook, PowerPoint, Project), Agile, ABRA Suite (HR), Maximo, MRO programs, SAP, TEDS, ComplianceWire, and Gallup online tools.
- Hands-on experience in equipment qualification, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Preferred experience in DOE (using Minitab), with additional skills in Computer System Validation (CSV), SOP development, and change control for medical devices.
- Experience in process validation (from process characterization through OQ and PQ), statistical analysis, process FMEA, and first-time quality.
- 1st shift