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Complaint Analyst
From:
Company: LifeCell Corporation (see all of this employer's jobs)
Phone: 9089471022
Fax: 1234567890
 Apply by eMail:do_not_reply@invalidemail.com
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Job Reference ID:
5146323
Category:
Scientific
Duration:
Fulltime, Permanent
City, ST:
Branchburg, New Jersey
Country:
United States |
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Description:
JOB SUMMARY/PURPOSE:
Responsible for timely investigation of safety information related to LifeCell’s marketed products.
PRINCIPAL RESPONSIBILITIES:
1. Participates in all aspects of product complaint investigation including:
Ensuring completeness of initial complaint entry.
Investigate production, distribution and related complaints for each lot and review donor file for human tissue product complaints using a systemic approach.
Perform root cause analysis and provided complaint conclusion in timelines defined in SOP.
Enter information in Trackwise.
Participate in Committee Review of complaints.
Assists in data collection for management review and Post- market surveillance.
Assists in providing feedback to other LifeCell Departments for continuous process improvements.
Reviews effectiveness of corrective actions as related to product complaints.
Supports Clinical Operations with investigation of reported Serious Adverse Events.
2. Adverse Event Reporting
Complete required regulatory forms for Adverse Event reporting and submitting to appropriate regulatory agency as defined in SOP for both human tissue and medical device products.
Apply by eMail:do_not_reply@invalidemail.com
Job Created:
Wed Oct 28 2009 07:02:00 AM
Last Modified: Sat Nov 21 2009 07:13:08 AM
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