Quality Assurance Associate

This position is responsible for supporting regulatory compliance, quality management, and vendor qualification processes. The role ensures adherence to regulatory requirements and internal procedures related to product quality, labeling, and compliance. Additional responsibilities include reviewing vendor documentation, maintaining regulatory databases, supporting various business units with regulatory and quality-related inquiries, and participating in special projects.

Key Responsibilities:

• Support compliance of the Quality Management System with regulatory requirements (e.g., ISO 13485, MDSAP, 21 CFR part 211, 820, 803, 806).
• Manage the Regulatory Item Creation Inbox and maintain item creation attributes.
• Verify UDI barcodes to ensure compliance with FDA requirements.
• Review and approve packaging and labels for private-label products to ensure regulatory compliance.
• Resolve PIX regulatory errors efficiently.
• Create, update, and revise standard operating procedures, work instructions, and forms.
• Maintain the Global Inspections Tracker (i360).
• Review and approve new vendor qualification documents for onboarding.
• Provide regulatory and quality assurance support to Corporate Brand Development, Marketing, and other Business Units.
• Research and address quality and regulatory matters affecting business operations.
• Secure and maintain company licensure and product registrations as needed.
• Perform clerical functions, including but not limited to copying, filing, scanning, and faxing.
• Participate in special projects and other assigned duties.

General Skills and Competencies:

• Strong understanding of industry practices, FDA regulations, and quality assurance standards.
• Proficiency with regulatory tools, systems, and compliance procedures.
• Effective verbal and written communication skills with excellent customer service abilities.
• Strong organizational, planning, and time management skills with the ability to handle multiple projects under pressure.
• Ability to follow written SOPs and formal procedural documents accurately.
• Strong attention to detail and ability to ensure verbatim compliance with procedures.
• Problem-solving and decision-making skills with the ability to interpret written, oral, diagram, or schedule-based instructions.
• Ability to work independently, adapt to changes, and participate in continuous improvement initiatives.