Senior Quality Assurance Associate

Aurobindo Pharma USA, Inc.; Hightstown (NJ); Presencial; USD 37.000 - 40.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical plans

Dental plans

Vision plan

Life insurance

Disability insurance

401(k) plan

EAP

PTO

Descripción de la vacante

Aurobindo Pharma USA, Inc. is seeking a Senior Quality Assurance Associate to provide strategic QA support to warehouse and distribution operations. The role ensures compliant receipt, inspection, and release of pharmaceuticals, adhering to 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 regulatory interactions.

Formación

• B.S. degree in a scientific field is required.
• 2–3 years of QA experience in the pharmaceutical industry.
• Familiarity with GMP, GDP, DSCSA, and regulatory requirements preferred.
• Strong data collection, analysis, and documentation skills.
• Experience with Oracle is a plus.

Responsabilidades

• Lead receipt and inspection in compliance with GDP, DSCSA, and regulatory requirements.
• Verify DSCSA serialization and chain of custody documentation.
• Identify and manage suspect or illegitimate product reports.
• Monitor warehouse environmental conditions and storage compliance.
• Inspect returned goods for regulatory disposition.
• Prepare and approve QA documentation (SOPs, procedures, work instructions).
• Investigate deviations and nonconformances; implement CAPAs as needed.
• Support product release documentation review and approval.
• Contribute to continuous improvement of QA processes and regulatory compliance.

Conocimientos

GMP knowledge

Communication skills

Data collection & analysis

Attention to detail

Microsoft Office

Organizational & leadership

Verbal & written teamwork

Educación

B.S. degree (scientific field)

2-3 years QA pharma experience

Oracle experience (preferred)

Herramientas

Oracle

Descripción del empleo

Division Overview

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages.

Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

Job Overview

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.

Work Schedule

Monday through Friday, 10:30am to 7:30pm

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.

Qualifications - Skills & 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.

Education & Experience

• 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 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

Compensation

Min

USD $27.00/Hr.

Max

USD $29.00/Hr.

Physical Requirements

WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur 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.

Additional Physical Requirements

Walking 1-4 Hours

Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.