US PharmaLab Inc.

Compensation

Full Description

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