Regulatory Compliance Coordinator II

Overview

The Compliance Coordinator II is responsible for document compliance with FDA regulations and company standards as well as providing staff support related to documentation and records.

• Manage document control program and document register;
• Assist document owners as necessary with proper document content and use of Harlan Internet Portal (HIP);
• Centralize and maintain population of data for finished goods in ESM;
• Centralize and maintain population of data for raw ingredients and packaging in ESM;
• Work directly with members of the Purchasing group to centralize, obtain and maintain required vendor documents in order to be SQF and FDA compliant;
• Centralize and maintain approved supplier register;
• Centralize and maintain approved contractor/vendor documents;
• Centralize and maintain safety data sheet library in HIP;
• Centralize and maintain lock-out/tag-out library in HIP;
• Assist in preparation of documents and records for SQF/other audits;
• Continually look for and develop ways to maintain and improve compliance with applicable laws, regulations and codes while supporting other departments (such as R&D and Quality) to do the same;
• Serve as back-up to packaging and information coordinator;
• Performs other required tasks as assigned.

• Associates or bachelor's degree from an accredited college or university preferred;
• Minimum of 2 years of food manufacturing experience preferred;
• Familiar with food manufacturing, safety and quality process concepts, practices, and procedures;
• Working knowledge and previous experience with Genesis nutrition software preferred;
• Previous project management and/or documents and records control experience;
• Previous management of customer specification and technical documents preferred;
• Maintain flexibility in order to support ever-changing regulatory and customer requirements;
• Excellent problem-solving skills with the ability to work in a collaborative environment;
• Knowledge of and previous experience with FDA food labeling requirements preferred;
• Knowledge of and previous experience with GFSI platforms, specifically SQF, is highly preferred;