QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records. Fully bilingual.

Key Responsibilities:

• Ensures quality of complaint records
• Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Executes against prioritized work plans
• Quickly escalates issues that could impede the ability to close records according to action plans
• Maintains compliance with local and global processes
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides guidance and technical advice
• Evaluates subject matter expert assessments
• Escalates potential Quality issues to Management

• Doctorate or Master’s degree in Sciences & 3 years of investigation experience or
• Bachelor’s degree in Sciences & 5 years of investigation experience.

• It is a Non-Standard/Administrative shift.