QA Lead: GDP/DSCSA Compliance for Pharma Distribution

Aurobindo Pharma USA, Inc.; East Windsor Township (NJ); Hybrid; USD 37,000 - 40,000; Full time

Benefits offered by this job

Medical and Rx Benefits - Horizon

Dental Benefits - CIGNA

Vision Plan - VSP

Life Insurance

Job summary

Aurobindo Pharma USA, Inc. is hiring a Senior Quality Assurance Associate to support warehouse and distribution operations by ensuring compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import rules.

The role manages deviations, supplier quality assessments, CAPA closure, and regulatory documentation while partnering with Quality leadership on cross-functional initiatives and regulatory interactions.

Qualifications

• Minimum B.S. degree; preferably in a scientific field.
• 2–3 years of experience in Quality Assurance or a similar pharmaceutical role.
• Oracle experience is preferred.

Responsibilities

• Lead receipt and inspection of products for GDP, DSCSA and regulatory compliance.
• Verify DSCSA serialization, lot traceability, and chain of custody docs.
• Identify and manage suspect or illegitimate product reports.
• Monitor warehouse environmental conditions and storage compliance.
• Inspect returned goods for disposition and regulatory compliance.
• Write, revise, and approve QA documentation (SOPs, procedures).
• Investigate deviations and nonconformances; support product release QA review.
• Support continuous improvement activities for quality and regulatory compliance.

Skills

MS Office

Organizational skills

Data analysis

Attention to detail

GMP knowledge

Communication skills

Teamwork

Education

BS degree

Tools

Oracle

Job description

Aurobindo Pharma USA, Inc. is hiring a Senior Quality Assurance Associate to support warehouse and distribution operations by ensuring compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import rules.

The role manages deviations, supplier quality assessments, CAPA closure, and regulatory documentation while partnering with Quality leadership on cross-functional initiatives and regulatory interactions.