Senior QA Associate - Pharma Distribution & Compliance

Aurobindo Pharma USA, Inc.; Hightstown (NJ); On-site; USD 37,000 - 40,000; Full time

Benefits offered by this job

Dental Benefits

Vision Plan

Life Insurance

401(k) Plan

EAP

Job summary

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide quality support for warehouse and distribution operations. You will ensure compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import regulations.

Manage deviations, lead supplier quality assessments, and drive CAPA closure while maintaining regulatory documentation. The role requires strong GMP knowledge, data analysis, and communication skills to support

Qualifications

• Minimum B.S. degree; preferably in a scientific field.
• 2-3 years of experience in Quality Assurance or a similar field within the pharmaceutical industry.
• Oracle experience (preferred).

Responsibilities

• Lead receipt and inspection of pharmaceutical products for compliance with GDP, DSCSA and regulatory requirements.
• Verify DSCSA serialization, lot traceability, and chain of custody documentation.
• 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, work instructions).
• Investigate and resolve deviations and nonconformances.
• Execute QA review and approval of product release documentation.
• Support continuous improvement activities to enhance Quality operations and regulatory compliance.

Skills

Microsoft Office

Leadership

Data analysis

Attention to detail

GMP knowledge

Communication

Teamwork

Education

B.S. degree in a scientific field

2-3 years QA experience

Oracle experience

Job description

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide quality support for warehouse and distribution operations. You will ensure compliant receipt, inspection, and release of pharmaceuticals under GDP, DSCSA serialization, and FDA import regulations.

Manage deviations, lead supplier quality assessments, and drive CAPA closure while maintaining regulatory documentation. The role requires strong GMP knowledge, data analysis, and communication skills to support