Quality Assurance and Regulatory Compliance Specialist

Position Summary

The Quality Assurance and Regulatory Compliance Specialist is responsible for supporting the development, implementation, and maintenance of the quality assurance (QA) and regulatory compliance programs for the manufacturing and distribution of dietary supplements. This individual ensures that all products meet or exceed applicable regulatory requirements (FDA, cGMP, etc.) and internal quality standards while fostering a culture of continuous improvement and accountability across the organization.

• Manage new ingredient approval process – Collect and review ingredient documentation. Evaluate ingredient for usefulness and impact of change. Manage the approval process.
• Manage supplier approval program – Collect, review, and maintain current supplier documentation. Perform audits of ingredient and component suppliers, co-packers and co-manufacturers.
• Manage Halal program – Complete finished product Halal submission forms. Collect and maintain Halal ingredient paperwork. Develop Halal compliance procedures as needed.
• Perform finished product label and related marketing material review, ensuring compliance with regulations.
• Perform mock recalls and related follow ups.
• Develop and maintain finished product regulatory documentation to support sales.

• Foster a culture of quality and compliance throughout the organization.
• Support third party audits and regulatory inspections.
• Support complaint review and investigation.
• Support sales documentation requests.
• Support SOP review, implementation, and training.
• Support HACCP Plan development and review, including hazard analysis.

• Bachelor’s degree or equivalent
• The candidate must be legally authorized to work in the United States.
• Language proficiency – Proficiency in English is required.
• Computer skills – Possess good computer skills and competence in using Microsoft Office applications.
• Communication skills – Demonstrate strong communication (verbal, written, presentation) skills.
• Task Management – Works in coordination with assigned project plans and goals.
• Attention to detail – Ability to perform routine tasks by ensuring quality parameters are consistently followed and deviation from SOPs are addressed or reported.

Able to work in an environment that is exposed to powders, chemicals, food allergens, and other potentially sensitizing substances.