Senior Quality Assurance Associate

About the Company

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor, and a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Founded in 1986 and headquartered in HITEC City, Hyderabad, Aurobindo Pharma USA is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals. The company leverages vertical integration and efficient controlled processes to provide superior customer service in the distribution of over 450 individual product packages across more than 180 product families. Aurobindo operates in over 125 countries, markets over 80% of the top 100 most prescribed products globally, and is ranked 2nd among pharmaceutical companies based on total prescriptions dispensed.

About the Role

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.

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.

Requirements

• 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.
• Good knowledge of Microsoft Office applications.
• Strong knowledge of GMP regulations and their application.
• Oracle experience (preferred).

Skills

• Organizational and leadership skills.
• Excellent data collection and analysis skills.
• Keen attention to detail and critical/logical thinking.
• Demonstrated ability to communicate technical information or complex situations clearly and concisely.
• Excellent verbal, written, and teamwork communication skills.

Benefits

• Medical and Rx Benefits: Choice of four medical plans through Horizon; Rx automatically provided with medical benefits.
• Dental Benefits: Three dental plan options through CIGNA.
• Vision Plan: 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).
• FSA (Flexible Spending Accounts): Both Health Care & Dependent Care available.
• HSA (Health Savings Account).
• 401(k) Plan: Through Fidelity with 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, and holidays.

Pay

Min USD $27.00/Hr. – Max USD $29.00/Hr.

Physical Requirements

• Regularly lift and/or move objects 10-50 lbs.
• Frequently required to stand, walk, stoop, kneel, crouch, or crawl.
• Occasionally required to sit and climb or balance.
• Specific vision abilities required: close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Subject to environmental conditions: protection from weather conditions but not necessarily from temperature changes; activities occur both inside and outside.
• Medium work: exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
• Walking: 1-4 hours.
• Blood/Fluid Exposure Risk: Category III (no exposure to blood, body fluids, or tissues).