Biospecimen Quality and Reconciliation Specialist Job at Amgen (Hyderabad)

Job Responsibility

Accountable for cross-system reconciliation
Accountable for discrepancy queue management and pre-shipment resolution
Accountable for validation of results imports (automated and manual) including second-person verification controls
Accountable for data management interface validation prior to exports
Accountable for final results completeness verification and samples-not-resulted reporting
Accountable for database lock reconciliation and evidence package preparation
Accountable for Sample Data Change reporting cadence and Vendor Issue Log review
Accountable for disposition governance (withdrawals, consent not obtained, compromised samples)
Accountable for end-of-study operational checks and archive-ready documentation
Accountable for identifying systemic discrepancy trends and recommending corrective actions

Master’s degree & 3 years of experience with a strong Knowledge of clinical trials
Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials
Prior experience in biospecimen operations and management in relation to clinical trials
Strong reconciliation and cross-system validation logic
Root cause analysis capability across vendor, site, and system issues
Knowledge of data base lock processes and regulatory documentation standards
High-detail orientation with investigative rigor
Understanding of consent-based restrictions and disposition workflows
Ability to operate independently as quality control layer
Risk sensitivity regarding blinded data and final transfer integrity
Audit defensibility mindset