Senior QA Associate: GMP & DSCSA Compliance Leader

Acrotech Biopharma Inc; Hightstown (NJ); On-site; USD 37,000 - 40,000; Full time

Benefits offered by this job

Medical plans through Horizon

Rx benefits with medical

Dental benefits with CIGNA

Vision plan with VSP

Life and AD&D insurance

Disability insurance

401(k) plan with employer match

Employee Assistance Program (EAP)

Job summary

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

Work Schedule: Monday through Friday, 10:30am to 7:30pm. You will lead deviations, supplier QA assessments, CAPA closure, regulatory documentation, and collaborate with Quality leadership on cross‑functional

Qualifications

• B.S. degree in a scientific field preferred.
• 2–3 years of QA or similar experience in pharma.
• Knowledge of GMP regulations and DSCSA/ GDP basics.

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

Organizational skills

Leadership

Attention to detail

Critical thinking

Verbal and written communication

Education

B.S. degree

Tools

Oracle

Job description

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

Work Schedule: Monday through Friday, 10:30am to 7:30pm. You will lead deviations, supplier QA assessments, CAPA closure, regulatory documentation, and collaborate with Quality leadership on cross‑functional