Join Grifols, a global healthcare company, as a Quality Assurance Validation Specialist. Enhance the lives of millions by working on improving healthcare. Review and approve IOQ protocols and reports, ensure validation documentation is complete and accurate, and work closely with various teams to develop and improve validation procedures.
Requirements
- Review and approve IOQ protocols and reports
- Ensure validation documentation is complete, accurate, and traceable
- Review Work Orders related to equipment maintenance, calibration, or qualification
- Ensure all work is documented properly and complies with Good Documentation Practices (GDP)
- Ensure validation activities comply with GMP, FDA, Health Canada, or other applicable regulatory guidelines
- Identify gaps or deviations in validation documentation and ensure appropriate corrective actions are taken
- Work closely with validation engineers, quality control, manufacturing, and maintenance teams
- Provide QA input during validation planning and execution phases
- Contribute to the development and improvement of validation procedures and templates
- Participate in audits and inspections, providing validation documentation as needed
- Review of Deviations, Investigations, and CAPA
- Review of procedure, Batch Productions Records (BPRs), logbooks, reports, and any documentation generated by Manufacturing, Validation and other departments
- Review/Approval of Quality and Operations Activities and Documents (logbooks, room / equipment status, training records, investigations, etc.) in relation to Change Requests, and Deviations, Investigations, and CAPA, as needed
- Review/approval of quality systems such as Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation
- Coordinate periodic review of procedures and other quality documents
- Initiate Deviations, Investigations, CAPA, Change Requests related to GMP documents / processes, as required
- Ensure the integrity and traceability of all data generated and reported
- Generate new procedures and revise existing procedures, as required
- Gather Deviations, Investigations, CAPA and Change Request data for Annual Product Reviews
- Provide cross departmental support to production, QC, validation and engineering
- Develop and Report Quality Metrics for Quality systems, as assigned
- Perform additional Quality System program responsibilities as trained on and assigned
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
