The Quality & Regulatory Affairs Specialist plays a critical role in upholding the highest standards of product quality and regulatory compliance within our manufacturing operations. This position is responsible for implementing and maintaining quality management systems, conducting internal audits, managing regulatory submissions, and supporting compliance with FDA, cGMP, and other relevant industry regulations. The Specialist also ensures product labeling and nutritional information meets all applicable standards, contributing to the success, safety, and integrity of the organization.

ESSENTIAL JOB FUNCTIONS & DUTIES INCLUDE BUT ARE NOT LIMITED TO:
• Develop, implement, and sustain quality management systems in alignment with company policies and regulatory requirements.
• Conduct regular internal audits and inspections to evaluate quality processes and identify compliance risks or areas for improvement.
• Collect and analyze quality data to drive process improvements and recommend corrective/preventive actions.
• Investigate and resolve non-conformances, customer complaints, and deviations from quality standards.
• Ensure compliance with FDA regulations, cGMP, and other applicable regulatory requirements across all products and processes.
• Prepare and submit regulatory filings and documentation, ensuring accuracy, completeness, and timeliness.
• Serve as a resource for regulatory guidance to cross-functional teams, including production, R&D, and sales.
• Maintain organized and up-to-date documentation related to quality and regulatory activities, including SOPs, audit findings, and change controls.
• Review and approve product release documentation, confirming all quality and compliance standards are met.
• Create and update Supplement and Nutrition Facts Panels manually for all products, ensuring compliance with FDA labeling regulations.
• Validate accuracy of product labeling, including ingredients, allergens, usage instructions, and warnings.
• Support company audits, including customer and third-party inspections, by providing documentation and process insights.
• Perform additional duties or special projects as assigned by management.

Education:
o (High School Diploma or equivalent required.
o Bachelor's degree in Quality Management, Regulatory Affairs, Food Science, Biology, Chemistry, or a closely related field preferred.
• Experience:
o Minimum of 2 years of experience in QA and/or regulatory compliance within nutraceutical, pharmaceutical, or food manufacturing.
• Qualifications:
o Strong working knowledge of FDA, cGMP, and food safety standards.
o Experience with regulatory submissions, internal audits, and customer complaint investigations.
o Familiarity with product labeling regulations, including creation and verification of nutritional facts panels.
o SQF Practitioner certification or training highly preferred.
o Exceptional attention to detail and accuracy in documentation, analysis, and compliance efforts.
o Proficient in data analysis and use of quality metrics to drive continuous improvement
o Strong written and verbal communication skills, with the ability to effectively collaborate across departments.
o Demonstrated organizational and time management abilities to manage multiple priorities and deadlines.
o Proficient in Microsoft Office Suite (Excel, Word, Outlook); experience with quality management software a plus.
o Ability to perform work in varied environmental conditions (including loud, hot, or cold environments).