Engineering Support NOS

Description Kelly Engineering Resources has an excellent contract-to-hire opportunity for a Global Products Safety & Complaints Analyst in the northern suburbs of Chicago. Our Customer is a leader in the pharmaceutical industry.
Job Scope:
Responsible for managing a GPSC event through its entire life-cycle, from initial triage referral through regulatory reporting, sample retrieval, investigation, and ultimately to closure/reopening as needed. Analyst is also responsible for knowing when an event is sufficiently complex with significant consequences to escalate the event to the Team Lead.
Job Responsibilities:
1. Primary, single source customer contact. 2. Responsible for gathering event registration information (as defined by SOP's) from customers. 3. Owns and manages the event through life-cycle from registration through regulatory reporting (if required), sample retrieval, investigation, and ultimately to closure/reopening as needed. 4. Responsible for contacting SME's, GPSC Support Services, Safety Physician and Team Managers as needed to obtain complaint closure. Need to know when to escalate events to the Team Manager for reassignment to Sr. GPSC Analyst. 5. Responsible for creating the draft regulatory report for review by the GPSC Regulatory Reporting/ Risk Management Support Function.
Job Qualifications:
* Bachelors Degree required, preferably in Business or a Scientific field. * Minimum three years of 'call center' experience, fielding technical questions from Internal and External customers. * Experience in a health care environment, within a bio-medical engineering discipline, and/or within a quality/compliance or safety organization in an FDA regulated business required. * Drug or Medical Device background highly preferred. This person will be fielding calls about product, and filling out appropriate FDA (if necessary) paperwork. * Attention to detail is critical - FDA form experience a plus * Excellent customer service (phone) skills required - customer service mentality a must! * Requires the ability to speak effectively to Bio-Medical Engineers, Manufacturing personnel and/or Health Care providers in order to gather the necessary detailed data from customers and convey product safety or quality issues.
In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:
* Competitive pay * Access to a comprehensive employee benefits package including health, prescription, vision, dental, and life and short-term disability insurance * Paid bonus and holidays * Portable 401(k) plans * Recognition and incentive programs * Access to continuing education via the Kelly Learning Center
For immediate consideration, click the 'Apply Now!' button, or refer a friend by clicking the 'E-mail this job' link provided.
Kelly Engineering Resources® specializes in providing companies around the world with qualified engineers, designers, drafters, and technicians. We are part of Kelly Services®, a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.
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