Senior QA Associate - GMP/DSCSA Compliance Leader

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

Benefits offered by this job

Medical plans

Dental plans

Vision plan

Life insurance

Disability insurance

401(k) plan

EAP

PTO

Job summary

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic QA support to warehouse and distribution operations. The role ensures compliant receipt, inspection, and release of pharmaceuticals, adhering to GDP, DSCSA serialization, and FDA import regulations.

You will independently manage deviations, lead supplier quality assessments, drive CAPA closure, and maintain regulatory documentation while supporting cross-functional regulatory interactions.

Qualifications

• B.S. degree in a scientific field is required.
• 2–3 years of QA experience in the pharmaceutical industry.
• Familiarity with GMP, GDP, DSCSA, and regulatory requirements preferred.
• Strong data collection, analysis, and documentation skills.
• Experience with Oracle is a plus.

Responsibilities

• Lead receipt and inspection in compliance with GDP, DSCSA, and regulatory requirements.
• Verify DSCSA serialization and chain of custody documentation.
• Identify and manage suspect or illegitimate product reports.
• Monitor warehouse environmental conditions and storage compliance.
• Inspect returned goods for regulatory disposition.
• Prepare and approve QA documentation (SOPs, procedures, work instructions).
• Investigate deviations and nonconformances; implement CAPAs as needed.
• Support product release documentation review and approval.
• Contribute to continuous improvement of QA processes and regulatory compliance.

Skills

GMP knowledge

Communication skills

Data collection & analysis

Attention to detail

Microsoft Office

Organizational & leadership

Verbal & written teamwork

Education

B.S. degree (scientific field)

2-3 years QA pharma experience

Oracle experience (preferred)

Tools

Oracle

Job description

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic QA support to warehouse and distribution operations. The role ensures compliant receipt, inspection, and release of pharmaceuticals, adhering to GDP, DSCSA serialization, and FDA import regulations.

You will independently manage deviations, lead supplier quality assessments, drive CAPA closure, and maintain regulatory documentation while supporting cross-functional regulatory interactions.