Label Compliance Specialist

Summary

The Label Compliance Specialist supports regulatory compliance for product labeling, ingredient statements, nutrition facts, claims, and formulations in alignment with FDA regulations (21 CFR Part 101) and applicable certification standards. This role partners with R&D, Marketing, Quality, and Supply Chain to support compliant product development and commercialization while serving as a technical resource for labeling, claims, and ingredient compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Reviews and approves product labels to ensure compliance with FDA labeling regulations, including nutrition facts, ingredient statements, allergen declarations, and required statements.
• Reviews and assesses on-pack and marketing claims (e.g., “natural,” “non-GMO,” “free from”) for regulatory and certification compliance.
• Supports the development, maintenance, and organization of claim substantiation documentation.
• Ensures label updates are completed accurately and within established timelines.
• Reviews ingredients, formulations, and specifications for compliance with FDA regulations, GRAS status, food additive approvals, and customer requirements.
• Supports change management activities related to ingredient, formulation, or specification updates.
• Maintains ingredient and formulation compliance records and documentation.
• Certification & Audit Support
• Ensures assigned products meet requirements for applicable certifications (e.g., Non-GMO, Kosher, Halal).
• Collaborates with external resources to identify and address labeling and formulation compliance risks.
• Supports certification audits and tracks assigned corrective actions.
• Regulatory Monitoring & Cross-Functional Support
• Monitors applicable domestic and international labeling regulations and supports awareness of emerging requirements.
• Collaborates with internal partners to identify and address labeling and formulation compliance risks.
• Provides regulatory guidance during product development, commercialization, and change implementation.

Qualifications

• Bachelor’s degree in science, business, or another related field required.
• Minimum of 3-5 years of food regulatory experience required.
• Experience supporting domestic and international food regulations, required.
• Experience working with product information and manufacturing systems (e.g., PLM, ERP, Genesis), required.
• Experience supporting certification or claim programs (e.g., Non-GMO, Kosher, Halal), preferred.

Other Knowledge, Skills, And Abilities

• Judgment: Forms sound opinions and make solid decisions.
• Ethical: Acts with integrity and aligns behavior to organizational values.
• Quality Commitment: Consistently strives to meet high standards of excellence.
• Collaborative: Partners with others to realize better results.
• Customer Focused: Understands and responds effectively to stakeholder needs.
• Problem Solver: Identifies root causes and recommends effective solutions.
• Detail-oriented: Ensures accuracy and precision in work output.
• Organized: Structures work and information in a logical, efficient, manner.
• Prioritizes Effectively: Identifies and focuses on the most critical responsibilities.

CERTIFICATIONS

• None.

Additional Information

• WORK LOCATION: This role is expected to be onsite at our Pleasant View location in Plymouth, WI 3 days per week and may work remotely 2 days per week.
• Remote work must be performed within Wisconsin or another approved state in accordance with company policy.
• Travel Requirements: Occasional Travel (up to 10%) – Limited travel for training, meetings, or visits to other Sartori manufacturing facilities.