What are the responsibilities and job description for the Quality Assurance Associate position at Aurobindo Pharma USA, Inc.?
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
A Quality Assurance Inspector monitors the Quality of the incoming products. Perform regular product evaluations according to Specifications. Temporary role, 3 month duration, potential to be converted to permanent after the duration (not guaranteed).
Responsibilities
- Handling product complaints: initiating/receiving, processing and closing as per applicable standard operating procedures (SOP).
- Request complaint samples if required to conduct the investigation.
- Interacting and following up with the customer/PVG to acquire information that may be required to effectively investigate a product complaint.
- Reviewing the final investigations received from the manufacturing units to ensure accuracy.
- Following up with Corrective Action/Preventative Action plans to ensure technical issues are being addressed.
- Provides information needed for status of recall, FARS, quarantines, and product returns to the recalling manufacturer.
- Responds to inquiries made by management to resolve customer needs or concerns, including recall instructions, and product listing information.
- Collaborates with internal stakeholders as required.
- As deemed necessary, to assist in the handling and processing of field alert reports to FDA.
- Completing the weekly, monthly, and quarterly metrics as required by the compliance team.
- Update spreadsheets for compliants and FARS.
Qualifications - Skills & Requirements
- Good knowledge of Microsoft Office applications.
- Analytical skills.
- Organizational and leadership skills.
- Excellent written communication skills.
- Keen attention to detail, and Critical/logical thinking.
Education & Experience
- Previous experience in quality assurance or similar filed preferred.
- Good communication skills both verbal and written.
- Excellent data collection and analysis skills.
- Strong attention to detail.
- High School Diploma or GED.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements
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.
