Biospecimen Quality and Reconciliation Specialist

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Accountabilities

• 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.

Competencies

• 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.

Qualification

• Master’s degree & 3 years of experience with a strong Knowledge of clinical trials OR
• 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.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.