What are the responsibilities and job description for the Quality Complaint Contractor position at Source One Technical Solutions?
Source One is a consulting services company and we’re currently looking for the following individual to work as a fully onsite consultant to our direct client, a global pharmaceutical company in San Diego, CA.
Job Title: Quality Complaint Contractor
Pay Rate: $35.72/hr (W-2)
40 hours/week, Mon-Fri
Duration: This position is open to cover a worker on a leave of absence so currently this will be a firm 6-month position, however, if the candidate shows strength and the budget warrants, they may be considered to extend or convert to permanent.
This is a post-market complaint handling role, handling approximately 5 complaints per day.
Duties:
- Regularly monitors Complaint Handling inbox for new complaints and adverse event reports
- Generates complaints in the eQMS and adds data inputs to Master Complaint Tracker
- Attaches all relevant files and reports for the complaint to the eQMS, e.g. PC/AE reports, Follow-Up communications, Reportability Assessments, log files, etc.
- Organizes and generate Complaint folders in SharePoint to help with investigations and collaboration activities
- Performs DHR review for Complaint investigations
- Updates Complaint investigation summary with administrative information including complaint number, PC/AE report information, Device information, etc.
- Creates log files and attaches to the eQMS and SharePoint Complaint folder
- Monitors Handpiece returns inventory and places weekly requests with 3PL for return shipments
Skills:
- Must be strong with Excel, Word, SharePoint
- 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience
- Knowledge of QSR's and their application
- Complaint handling experience
- Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
- Ability to manage multiple responsibilities with a high degree of self-motivation
- Good written, oral, and interpersonal English communication skills
- Knowledge and experience using Electronic Quality Management System (OMNIFY) is helpful but will be taught so not required
- College degree and experience in complaint handling are preferred
Salary : $36
