Senior Quality Assurance Associate
Aurobindo Pharma USA, Inc.•East Windsor Township, NJ
•Onsite
About The Position
As a Senior Quality Assurance Associate, you will provide strategic quality support to warehouse and distribution operations. This role ensures compliant receipt, inspection, and release of pharmaceuticals through adherence to GDP, DSCSA serialization requirements, and FDA import regulations. You will independently manage deviations and nonconformances, lead supplier quality assessments, drive CAPA closure and verification, maintain regulatory compliance documentation, and support Quality leadership on cross-functional initiatives and regulatory interactions.
Requirements
- Good knowledge of Microsoft Office applications.
- Organizational and leadership skills.
- Excellent data collection and analysis skills.
- Keen attention to detail, and Critical/logical thinking
- Strong knowledge of GMP regulations and their application.
- Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.
- Excellent verbal, written, and teamwork communication skills.
- 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.
Nice To Haves
- 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.
Benefits
- Medical and Rx Benefits choice of four medical plans through Horizon.
- Rx automatically provided with medical benefits
- Dental Benefits with three dental plan options through CIGNA
- Vision Plan with two plan options through VSP
- Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
- Disability Insurance, Voluntary Short-Term Disability and State Disability
- Long-Term Disability (LTD), State (short term) disability – where applicable
- FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
- HSA (Health Savings Account)
- 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
- Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
- Critical Illness and Accidental Insurance
- Legal and Identity Theft Insurance
- Paid Time Off - Paid vacation, PTO, Holiday
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What This Job Offers
Job Type
Full-time
Career Level
Senior
