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