QA Product Complaint Coordinator

Aurobindo Pharma USA, Inc.East Windsor Township, NJ
1d$25 - $35Onsite

About The Position

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.

Requirements

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

Nice To Haves

  • Bilingual in Spanish preferred, not required

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
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