- Our client is looking for a QMS Quality contractor with 5-8 years of experience to support their quality group. This person will be responsible and for tasks supporting the Quality Management System. This person should possess and be able to apply a broad knowledge of Quality principles, practices and procedures. This person will provide supports elements including document control, global change control, quality event reports, CAPA, validation data and internal audit support. This individual will collaborate on continuous improvement efforts and contributes to QMS training for procedures and regulations.
- Support document control and records maintenance in accordance with corporate policy and the maintenance and implementation of Electronic Document Management System (EDMS) by assisting with requests, revisions, reviews and approvals of controlled documents, quality systems reports, validation records and training materials.
- Support ownership, collaboration, revision, approval and archival of policy and procedures, process documents and work instructions
- Assist with the change control system including assessing proposed project charters, performing operational impact assessment and maintaining a database to generate valuable metrics
- Participate in internal process audits in collaboration with Quality Management
- Participate in collecting/analyzing performance and quality data to support and assist with the maintenance of quality records and metrics: deviations, complaints, non-conformances, auditing, CAPA, validations (assay and system) and materials release and control.
- 5-8 years of quality experience with a recent background in IVD
- Experience and background in QMS principles
- IVD Clinical Diagnostic experience HIGHLY PREFERRED
- Experience with CLIA and CAP standards REQUIRED
- Familiarity with FDA and ISO regulation and standards.
- PMP and/or and Six Sigma Certification a huge plus
- Strong understanding of the clinical trials process
Remote: Quality Consultant (226900)