Senior QA Associate - Pharma Compliance & Release Lead

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

Benefits offered by this job

Medical plans

Dental plan

Vision plan

Life Insurance

Disability insurance

FSA/HSA

401(k) match

EAP

Paid time off

Job summary

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

The role ensures compliant receipt, inspection, and release of pharmaceuticals per GDP, DSCSA, and FDA import rules, while independently managing deviations and supplier quality assessments. You will drive CAPA closure, maintain regulatory documents, and collaborate across functions to support leadership on regulatory interactions and

Qualifications

• BS degree in a scientific field is required or preferred.
• 2–3 years of experience in Quality Assurance within the pharmaceutical industry is required.
• Oracle experience is preferred.

Responsibilities

• Lead QA activities for receipt, inspection and release of pharmaceutical products per GDP, DSCSA and FDA import rules.
• Verify DSCSA serialization and lot traceability documentation.
• Identify and manage suspect/illicit product reports and ensure regulatory compliance.
• Monitor warehouse conditions and storage compliance.
• Write, review and approve QA documentation (SOPs, procedures, work instructions).
• Investigate deviations/nonconformances and drive CAPA closure.
• Execute QA review and approval of product release documentation.
• Support continuous improvement in quality operations and regulatory adherence.

Skills

Microsoft Office

Leadership

Data analysis

Attention to detail

GMP knowledge

Communication

Verbal & written skills

Education

B.S. in a scientific field

2–3 years QA experience in pharma

Tools

Oracle

Job description

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

The role ensures compliant receipt, inspection, and release of pharmaceuticals per GDP, DSCSA, and FDA import rules, while independently managing deviations and supplier quality assessments. You will drive CAPA closure, maintain regulatory documents, and collaborate across functions to support leadership on regulatory interactions and