Regulatory Specialist

Koch Foods • Franklin Park, IL

412d • $49,920 - $58,240

About The Position

The Regulatory Specialist at Koch Foods plays a vital role in ensuring compliance with regulatory standards, particularly those set by the FDA. This position involves collaboration with various departments to support clinical trials, quality assurance processes, and chemistry manufacturing controls. The specialist will conduct research and manage projects related to regulatory submissions and compliance management, ensuring that all operations adhere to the necessary guidelines.

Requirements

• Bilingual in Spanish
• Experience in CGMP Management
• Knowledge of food processing and GMP
• Mid-level experience in regulatory affairs
• Proficiency in Microsoft Office
• 3 years of experience in a related field
• Strong analytical skills
• Experience with clinical trials
• Computer skills relevant to manufacturing and food safety
• Strong communication skills
• Knowledge of FDA regulations

Nice To Haves

• Experience with safety management in a manufacturing or food processing environment
• Familiarity with USDA regulations and food safety standards
• Ability to analyze problems and develop solutions
• Experience in training and directing personnel

Responsibilities

• Prepare and print necessary labels for production use.
• Prepare lab samples for courier pick-up.
• Complete and submit sample request forms to the lab.
• Ensure timely delivery of lab samples to the designated lab courier.
• Organize and file lab Certificates of Analysis (COAs).
• Print forms as necessary for Quality Assurance and production processes.
• Complete and maintain hourly breading reports for the Par-Fry process.
• Review inbound shipment documentation for accuracy and compliance.
• Generate a summary sheet of inbounding loads from the previous day.
• Review pre-shipment documentation for compliance verification.
• Conduct thorough pre-shipment reviews for accuracy and regulatory adherence.
• Submit labeling for USDA approval as needed.
• Create and submit USDA Generic Approvals when required.
• Review new and existing labels for USDA compliance.
• Provide necessary documentation for updating the Koch Foods Specification Database.
• Ensure packaging and artwork comply with USDA regulations.
• Support and participate in annual audits including BRC, Food Defense, PVP, and customer-specific audits.
• Update and create new QA procedures as necessary.
• Develop new forms or revise existing forms to align with QA and regulatory needs.
• Oversee and maintain the Supplier Approval Program.
• Assist in completing customer forms and questionnaires as requested.
• Provide support to USDA personnel in the absence of department leaders.
• Act as back-up for the labeling technician as needed.
• Generate weekly purchase orders for Chem-Station chemicals.
• Consolidate and review bi-monthly Chem-Station invoices for timely submission.

Benefits

• Health insurance
• Dental insurance
• 401(k)
• Paid time off
• Parental leave
• Vision insurance
• 401(k) matching
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Food Manufacturing
• Education Level: No Education Listed