Specialist, Regulatory Affairs and Specification

Description

The Regulatory Affairs and Specifications Specialist is expected to support internal and external customers with all regulatory labeling needs and requests, and to ensure that all food Monogram produces is packaged in a manner that complies with all applicable regulations. The role will be to create and process all labels and nutritional information and will manage the central specifications system.

The qualified individual should have significant previous experience of working in a regulatory environment and should have a strong understanding of the regulatory landscape for food labeling, and of all applicable legislation. The individual should possess the ability to ensure that the company’s specifications and labeling procedures comply with all prescribed regulatory standards. Strong technical knowledge of specifications and regulatory requirements for food labeling is critical to this role.

Essential Duties And Responsibilities

• Proofread customer product labels, nutritional information, and packaging, ensuring that all information is accurate and conforms with federal labeling guidelines.
• Create nutritional fact panels and ingredient statements for new formulations and when changes are made to existing formulations.
• Review and approve new packaging and create new case labels.
• Update 1Spec and other spreadsheets and folders as appropriate with new packaging and case label information.
• Ensure that raw materials, packaging goods, recipe, and finished goods information is created and accurately maintained in the specifications system.
• Troubleshoot and respond to issues and complaints that arise at the plant in relation to ingredients, packaging, or labeling.
• Verify and validate product claims and ensure documentation is in place.
• Submit label approvals, including temporary approvals, to USDA; create generic USDA approvals.
• Assist with acquiring necessary state and federal regulatory licenses as needed.
• Review and approve new raw materials, ensuring data is accurately recorded in 1Spec.
• Perform other duties as assigned.
  
  

NOTE: This list presents only the principal duties of the position and is not intended to be comprehensive. The duties and responsibilities listed above may be changed or supplemented at any time in accordance with business needs and conditions.

Qualifications

• Education: Bachelor's degree in food science, culinary arts, or a related field is required.
• Preferred Experience: Two or more years of experience in the food manufacturing industry. Experience in USDA or FDA labeling is highly preferred.
• Knowledge of FDA and USDA labeling requirements.
• Understanding of the food manufacturing industry and plant operations.
• Detail oriented with the ability to work with exceptional accuracy.
• Good problem-solving and decision-making skills.
• Excellent communication skills.
• Proficiency in using a variety of computer programs, including PDM and nutritional software systems, as well as Microsoft Office.
• Ability to work collaboratively with cross functional teams and customers.
• Self-starter and the ability to work independently.
• Strategic thinker and the ability to prioritize and manage multiple projects, tasks, and people concurrently.
• Ability to sit for prolonged periods of time in front of a computer.
• Ability to move about the facility on a regular basis to perform physical activities, such as, but not limited to, lifting items of up to 20 lbs. unassisted, bending, standing, climbing or walking.
• Visual and hearing acuity.
• Must be 18 years or older.