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Posted: Sunday, February 11, 2018 12:12 AM


Job Description

Complaints/CAPA Specialist


Administration of the complaint management process, including the receipt, documentation, processing, investigation, resolution, and closure of all product quality complaints and patient-related field events in compliance with regulatory requirements (21CFR Parts 210, 211, 820).
Act as primary point of contact for hospitals, pharmacies, physicians, health care professionals and patients submitting product complaints.
Conduct analysis of product returns (chain of custody, storage and disposal).
Act as the Subject Matter Expert (SME) of the complaint management process in internal audits and external quality system audits conducted by the FDA and other regulatory agency representatives.
Manage regulatory complaints and investigations process, support root cause analysis, and contribute to the corrective action and preventive action (CAPA) process.
Conduct regular reviews of complaint files to ensure compliance to regulatory requirements as well as internal company requirements.
Create complaint and related CAPA trend analysis reports and submit to management to ensure the early discovery of potential quality issues and the continual improvement of the companies’ products and processes.
Notify management of reported events requiring immediate action.
Perform other duties as may be required by management.


BS/BA degree in the life sciences
2-5 years of experience in Complaints/CAPA
A strong desire to learn more about Regulatory Affairs

For immediate consideration, please send most recent resume, in Word format, to and reference job# 12605

• Location: Central Jersey, Princeton, NJ

• Post ID: 51934787 newjersey is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018