QA Product Complaint Coordinator

Overview

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).

The QA Product Complaint Coordinator requires strong communication/customer service skills as this position deals with customers on a daily basis. The role requires a high level of organization and multi-tasking to handle a high phone call volume within the department. It also requires an analytical mind to analyze and summarize product complaint final investigations and the ability to work independently and efficiently since the department requires meeting strict timelines.

This position also assists in handling medical inquiries, intake/processing of adverse drug events (ADEs), and other projects as deemed appropriate.

• Handling product complaints: initiating/receiving, processing and closing as per applicable standard operating procedures (SOP).
• Prepare complaint samples for shipment to manufacturing unit for investigation.
• Interact with the customer/reporter on a daily basis to acquire information needed to effectively investigate a product complaint.
• Review final investigations received from manufacturing units to ensure accuracy.
• Assist in appropriately handling initial receipt of ADEs and processing as per SOPs.
• Assist in handling and processing of field alert reports to FDA as needed.

• Must be able to work in the US without requiring sponsorship.
• Cordial and responsible when talking to customers, complainants, or other associates.
• Very organized with high standard work ethics.
• Effective communication and attentive listening; ability to record information promptly and correctly on the appropriate documentation form.
• Cooperative when assigned other responsibilities.
• Proficient in Excel and Word.
• Bilingual in Spanish preferred, not required.

• Minimum of Bachelor of Science or equivalent professional experience.
• Minimum one year experience in Pharmacovigilance, Customer Service, or related role in the healthcare industry.

USD 25.00–USD 35.00 per hour

• Office position; able to stand, sit, talk, hear, and use hands and fingers to operate computer and telephone keyboard; reach, stoop, kneel to install computer equipment.
• Specific vision abilities required for computer work.
• Light to moderate lifting may be required.
• Moderate noise typical of a business office environment.
• Sedentary work with extended computer use; sitting most of the time and rare walking/standing.

No additional requirements. Blood/Fluid Exposure Risk:
Category III (no exposure to blood, body fluids or tissues).