Customer Complaint Specialist

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

#PS