Regulatory Compliance & Certification Consultant – Organic, Pharmaceutical, Gluten-Free

A 3PL (Third-Party Logistics) operation in Greenfield, Indiana is seeking an experienced Regulatory Compliance & Certification Consultant to support the organization in achieving Organic Certification (USDA Organic/CCOF/QAI), Pharmaceutical Compliance (cGMP, FDA 21 CFR 210/211), and Gluten-Free Certification (GFCO). The consultant will lead gap assessments, update documentation, implement facility and process improvements, train staff, and support all stages of the certification process.

Responsibilities:

• Conduct pre-assessment and full gap analysis against Organic, cGMP, and Gluten-Free standards
• Update or create SOPs, quality manuals, sanitation programs, allergen control plans, and traceability procedures
• Evaluate facility layout, workflows, cleaning and sanitation, storage, pest control, and segregation
• Develop contamination-prevention and traceability systems
• Train warehouse, QA, and operations teams on updated quality systems
• Prepare certification applications and coordinate with USDA Organic, GFCO, and FDA-related bodies
• Conduct internal mock audits and support corrective actions
• Provide on-site support during official audits

Qualifications:

• In-depth knowledge of USDA Organic, cGMP, 21 CFR 210/211, GFCO, and QMS/ISO standards
• Experience preparing warehouses, 3PLs, food distribution, or pharma logistics for certification
• Expertise in HACCP, FMEA, CAPA, and SOP development
• Strong project management and audit preparation experience
• Ability to train and collaborate with cross-functional teams
• Preferred: ASQ Auditor, PCQI, Lead Auditor training, or similar certifications

Job Type: Contract

Pay: $40.00 - $75.00 per hour

Expected hours: 40 per week

Work Location: In person