Job Description

Summary :

The Coordinator Regulatory will receive, resolve, and document corrective action for consumer and customer complaints within cGMP requirements. This includes reviewing history of product, maintaining the complaint database, etc. Researching the complaints includes communicating trends to applicable parties (FDA, consumer, customer), following up with departmental managers on complaints & reviewing product batch records for clarification. Will be responsible for communicating all research and corrective action measures taken to the customer or consumer. Leads and coordinates the team reporting on complaints and inquiries and supports their job functions as needed. Supplies reports on complaints & inquiry data.

Essential Duties and Responsibilities:

• Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day. Possess a sense of energy and initiative. Be pro-active
• Present for work when scheduled is a mandatory function
• Compliance with all company safety rules procedures and guidelines is essential
• Respond to all incoming product complaints originating from retail customers and/or end-users
• Provide timely and professional communication to retail customer or product end-users in accordance with documented procedures throughout complaint investigation process
• Maintain hard copy and electronic files of individual complaints. Complete reports and update electronic log with required information
• Retrieve retained product samples from various locations when necessary
• Investigate Batch Record of complaint lot for possible cause or internal defects when necessary
• Obtain customer product samples and supporting documentation (i.e., medical bills, repair estimates) when necessary
• Submit product samples for laboratory testing
• Request and compile complaint investigation information from various departments. Assist with investigations when necessary
• Mail replacement/complimentary product samples in accordance with government regulations
• Request refunds, and disperse to complainants
• Compose final reports and communicate results with complainants
• Evaluate and communicate trends to appropriate management
• Escalate customer complain investigations to Quality Assurance and CAPA when trends are identified
• Participate in internal, customer, and government agency audits

Supervisory Responsibilities:

None

Education Requirements:

Bachelor’s degree in science, related technical field, or equivalent experience

Experience Requirements:

A minimum of 2 years’ experience in a regulated industry is required. 2 years’ experience handling customer complaints preferred.A background in chemistry preferred. Personal computer proficiency required.

Competencies:

• Advanced knowledge of Excel and Word
• Good analytical skills
• Proficient in MS office (ability to create spreadsheets, databases)
• Technical writing skills, able to analyze data & track trends
• Requires excellent oral & written communication skills
• Excellent organizational skills
• Assures quality service to all customers
• Active listening
• Conflict resolutions
• Dependability
• Effective Communication
• Ability to use positive language
• Knowledge of the product
• Ability to interact well in team environment skills are necessary in this position due to the sensitivity of the communication with the customer

Certificates, Licenses, Registrations:

None

Travel:

None

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

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