Senior QA Lead - Pharma Quality & Compliance

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

Paid Time Off

Job summary

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic quality support to warehouse and distribution operations in New Jersey.

You will ensure compliant receipt, inspection, and release of pharmaceuticals under 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 initiatives and

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.
• Medical and Rx Benefits selection of four medical plans through Horizon; Rx provided with medical benefits.
• Dental, Vision, Life and Disability insurance options.
• 401(k) with employer match and vesting after 3 years.

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

GMP knowledge

Regulatory compliance

QA documentation

DSCSA knowledge

Data analysis

Communication skills

Education

B.S. degree in science

Oracle experience

Tools

Oracle

Job description

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic quality support to warehouse and distribution operations in New Jersey.

You will ensure compliant receipt, inspection, and release of pharmaceuticals under 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 initiatives and