Quality Certification Consultant
Hybrid · Greenfield, Indiana, United States
Job Summary
Regulatory Compliance & Certification Consultant for a 3PL seeking to lead Organic, pharmaceutical (cGMP), and Gluten-Free certifications. Responsibilities include conducting gap analyses, developing and updating SOPs and quality manuals, implementing traceability and contamination-prevention protocols, training staff, coordinating with certifying bodies, and supporting internal and external audits through certification approval. Location is on-site/hybrid at a 3PL facility in Greenfield, IN. Requires deep knowledge of USDA Organic, cGMP, 21 CFR Part 210/211, and GFCO standards, strong QMS/ISO expertise, SOP development, CAPA, HACCP/FMEA, audit experience, and excellent communication and project-management skills.
Required Qualifications
- In-depth knowledge of USDA Organic, cGMP, 21 CFR Part 210/211, and GFCO standards
- Experience preparing warehouses or 3PL operations for certification audits
- Strong background in Quality Management Systems (QMS) and ISO frameworks
- Expertise in SOP development, risk assessments (HACCP/FMEA), and corrective/preventive actions (CAPA)
- Familiarity with material traceability, allergen control, and contamination prevention
- Ability to evaluate facility design, process flows, and sanitation programs
- Strong audit preparation and execution experience
- Capable of training staff at all levels—from warehouse teams to leadership
- Excellent communication and documentation skills
- Strong project management and stakeholder-engagement abilities
- Ability to influence cross-functional teams and drive process adoption
- Preferred experience with manufacturing, food distribution, or pharmaceutical logistics
- Experience supporting multiple certifications simultaneously
- Industry-recognized certifications (e.g., ASQ Auditor, PCQI, Lead Auditor Training)
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