QA Product Complaint Coordinator
Acrotech Biopharma inc., Princeton Junction, New Jersey, United States
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 The QA Product Complaint Coordinator requires strong communication/customer service skills as this position deals with customers on a daily basis. This position requires a strong level of organizational and multi-tasking skills to handle a high phone call volume within the department. In addition, it is required to have an analytical mind to be able to analyze and summarize product complaint final investigations and be able to work independently and efficiently since the department requires meeting strict timelines.
This position is also responsible in the aiding of handling medical inquiries, the intake/processing of adverse drug events, as well as other projects as deemed appropriate.
Responsibilities
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.
Interacting/doing follow-up with the customer/reporter on a daily basis 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.
To assist in appropriately handling initial receipt of ADE and processing it as per applicable SOPs
As deemed necessary, to assist in the handling and processing of field alert reports to FDA
Qualifications
Must be able to work in the US without requiring sponsorship
Must be cordial and responsible while talking to customers, complainants or other associates
Must be very organized and possess high standard work ethics
Effective communication, attentive listening is a must. Skill to record the information received promptly and correctly on the appropriate documentation form is a must
Must be cooperative when assigned other responsibilities
Must be proficient in using Excel and Word
Bilingual in Spanish preferred, not required
Education & Experience
Minimum of Bachelor of Science, or equivalent professional experience.
Minimum one year experience working in Pharmacovigilance, Customer Service, or related role in Healthcare industry
Compensation USD $25.00/Hr. – USD $35.00/Hr.
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.
Exposure 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.
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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 The QA Product Complaint Coordinator requires strong communication/customer service skills as this position deals with customers on a daily basis. This position requires a strong level of organizational and multi-tasking skills to handle a high phone call volume within the department. In addition, it is required to have an analytical mind to be able to analyze and summarize product complaint final investigations and be able to work independently and efficiently since the department requires meeting strict timelines.
This position is also responsible in the aiding of handling medical inquiries, the intake/processing of adverse drug events, as well as other projects as deemed appropriate.
Responsibilities
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.
Interacting/doing follow-up with the customer/reporter on a daily basis 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.
To assist in appropriately handling initial receipt of ADE and processing it as per applicable SOPs
As deemed necessary, to assist in the handling and processing of field alert reports to FDA
Qualifications
Must be able to work in the US without requiring sponsorship
Must be cordial and responsible while talking to customers, complainants or other associates
Must be very organized and possess high standard work ethics
Effective communication, attentive listening is a must. Skill to record the information received promptly and correctly on the appropriate documentation form is a must
Must be cooperative when assigned other responsibilities
Must be proficient in using Excel and Word
Bilingual in Spanish preferred, not required
Education & Experience
Minimum of Bachelor of Science, or equivalent professional experience.
Minimum one year experience working in Pharmacovigilance, Customer Service, or related role in Healthcare industry
Compensation USD $25.00/Hr. – USD $35.00/Hr.
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.
Exposure 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.
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