(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory

Tasks

• Collaborate with quality assurance and cross-functional teams
• Communicate data quality issues and support corrective actions
• Compare transferred data against data transfer specifications
• Confirm reproducibility of calculations
• Coordinate solutions to improve clinical laboratory data quality
• Ensure ALCOA plus data integrity compliance
• Investigate data discrepancies and document QC observations
• Perform QC review of raw laboratory data
• Reconcile raw data processed results and reported outputs
• Review calculations for mathematical accuracy
• Review laboratory documentation for completeness and compliance
• Support deviation investigations root cause analysis and CAPA
• Support internal and external audits with traceability evidence
• Support protocol analytical method report and batch record review
• Validate Excel workbook formulas and data integrity controls
• Validate data transcription into LIMS
• Verify LIMS data entries and approvals
• Verify data traceability to source
• Verify electronic records and electronic signatures compliance
• Verify formula dilution factors and acceptance criteria
• Verify units formatting controlled terminology completeness

Perks/Benefits

• Adoption support
• Family building benefits
• Fertility support
• Fitness resources
• Healthcare benefits
• Mental health support
• Paid time off
• Savings and investments
• Surrogacy support
• Wellness and mindfulness support

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ALCOA plus | Annex 11 | Bioanalytical method validation | CFR Part 11 | Cell-based assays | Data Integrity | Data Reconciliation | Data transfer | Data transfer specifications | EU Annex 11 | Excel Validation | Flow Cytometry | GCP | GxP | Immunoassays | Information Management System | LCMS | LIMS | Laboratory Information Management | Laboratory Information Management System | Management System | Method validation | Part 11 | Quality Control | Statistical Analysis