MAU is hiring a Customer Complaint Specialist at our client in Deerfield Beach, FL. As a Customer Complaint Specialist , you will investigate and documentproduct complaints. This involves reviewing manufacturing records and deviations, examining returned samples, coordinating product evaluations, and analyzing complaint histories for trends. You will be tracking all investigations and assigned categories, aiming to identify root causes, implementing corrective actions, and preparing final reports following established procedures. This is a short-term contract assignment.
Benefits Package
Health, dental, and vision insurance
401k and 401k matching
Paid vacation and holidays
Paid time off
Opportunity for advancement
Health savings account
Shift Information 1st shift, Monday - Friday, 8:00 AM - 5:00 PM
Required Education and Experience Bachelor's degree in Science or Engineering
3 - 4+ years of experience in the pharmaceutical/medical device industry working with investigation processes in a manufacturing environment
General Requirements Knowledge and understanding of regulatory compliance, cGMP requirements for pharmaceutical/medical device manufacturing processes and operations
Commitment to quality and customer service
Excellent written and communication skills
Excellent organizational skills with the flexibility to react to changing deadlines and priorities
Demonstrated critical thinking and ability to pay close attention to detail and accuracy
Aptitude for and demonstrated use of computerized systems to run queries and reports
Self-motivated and able to work independently and in a team environment
Ability to simultaneously multi-task across multiple capabilities and functions and handle competing priorities and requirements (i.e., performing site and functional responsibilities, responding to frequent e-mail and phone communications, attending multiple meetings and conference calls, etc.)
Ability to work effectively under and manage strict production, time, and performance deadlines
Willingness to work beyond the hours typically defined as a "regular" workday, to possibly include weekends and holidays
Preferred Requirements 2+ years of complaint investigation experience
Essential Functions Understand customer/patient use of and manufacturing process for site-manufactured, packaged, and/or distributed products
Track receipt, investigation, and closure of product complaints to ensure adherence to established timelines
Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template
Identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation
Track and trend complaints, including provision of trend reviews/reports to customers, site, and corporate management, and for Annual Product Records Reviews
Assure regulatory compliance of the complaint program is maintained
Perform periodic reviews of program-related SOPs/processes and revise as necessary
Perform/document an assessment to assure alignment of site SOPs/processes requirements, close identified gaps through SOP revision or other actions
Support/conduct internal and external cGMP audits and regulatory agency inspections
Complete post-audit/inspection commitments
Support operations and quality management initiatives and objectives
Perform other tasks as assigned
Work Environment or Working Conditions This position requires regular onsite attendance and may need to be performed on a remote/rotational basis
Physical Demands
This position may require the following to be performed with or without reasonable accommodation. Ability to sit at a computer for extended periods of time
Ability to work effectively under and manage strict time and performance deadlines
Ability to lift and move up to 30 pounds
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