Customer & Quality Operation Specialist

Customer Quality Specialist

The primary mission of the Customer Quality Specialist will be the point of contact for customers for the North America Region for the Rx/CHC/Injectables Division for all matters relating to complaints. Manage customer's complaints, monitors quality indicators, prepares quality section related to complaints for customer reviews, and reports to the organization on the voice of the customer, customer feedback.

What We Are Looking For: Primary Duties and Responsibilities:

• Ensure administrative management of the complaint (recording, if applicable, internal distribution, samples requests, batch record analysis and customer communication, if applicable, filing, archiving, data management) of customer complaints for the site.
• Carry out, in a timely manner, the investigation as per work instruction in collaboration, if needed, with various site departments (e.g. production, logistics, or R&D in sites oversee) and identify potential root cause on each customer complaints for the site; Identify any recurring product-related issues.
• Initiate the corresponding preventive and corrective actions, facilitate their processing and help verify their implementation.
• Issue a complaint investigation report and follow up if needed with the customer or at the request of the customer.
• Be the point of contact for customers for the NAM Injectables Division for all matters relating to Quality complaints; Provides customers with the necessary information Coordinate on-site customer complaint follow up and ensure follow-up of defined actions.
• Monitors quality indicators, and prepare quality complaints section for customer reviews, Build partnerships with internal and external customers.
• Reports on the organization on the voice of the customer, customer feedback, Acts with a customer-oriented culture.
• Uses the processes and tools set up for customer quality complaint management to guarantee the harmonization and efficiency of activities to maintain and improve customer complaints management.
• Be a key user of claims management tool (EtQ). Identifies, prioritizes and resolves complaints to ensure customer satisfaction in compliance with quality standards and applicable regulatory requirements.

What You Will Bring On The Journey:

• Bachelor's Degree.
• Experience in a pharmaceutical company or medical device as customer quality or technical support, or in operations is a plus.
• Ability to interact with customers.
• Advanced knowledge of current Good Manufacturing Procedures (cGMP).
• Must be team-oriented and demonstrate the ability to work cross-departmentally throughout the manufacturing site.
• Ability to interpret and write complex documents.
• Advanced written, verbal, and interpersonal communication skills.
• 5 years' experience in Quality in ISO certified and/or FDA regulated manufacturing business.

Skills/Abilities: Good analytical skills. Self-Starter with good written and communication skills. Detail oriented and rigorous. Knowledge of ISO, GMPs, CFR 21 regulations. Strong computer skills. Strong problem-solving, Strong organization and time management skills. Strong team spirit, work ethic, and accountability. Must be flexible and adaptable.