Must have: QA, GMP, product complaint investigations and Trackwise
Primary responsibility is to perform and assist in the product quality complaint intake and investigation process utilizing QA-Track. Liaison with third party call centers, affiliates, and contract providers to facilitate the complaint investigation and closure process. Performs tracking, trending, and reporting of complaint metrics to ensure the Ferring US QA maintains a state of control. Leads and/or participates in the resolution and review of complaint investigations, and corrective/preventive actions (CAPAs).
This position profile is intended to describe the general nature and level of work being performed and to describe those functions that are essential to the performance of this job.
This position profile includes other duties and responsibilities that may be assigned to this position, which are incidental or secondary to the overall purpose of this job. This position may require other job-related duties as requested by area management.
Perform and assist in the complaint intake and investigation process through Trackwise to ensure proper documentation of drug product complaints, medical device complaints, and adverse events associated with product quality complaints.
A minimum of three (3) years of GMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry. Bachelor's degree in a natural sciences, pharmacy, or engineering from an accredited college or university preferred
Prior experience processing product quality complaint investigations including, but not limited to: field sample inspection, contract provider inquiries, data entry and trend reporting, and follow-up actions to drive complaint closure
Working knowledge following Standard Operating Procedure (SOP), document management/control system processes
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.