Title QA Regulatory Specialist
End Date 2017-10-30
Location Mundelein, IL
Job Information

Overview:

Assists in ensuring products meet regulatory labeling requirements for US and international export. Generates product label contents including ingredient statements and nutritional data to meet customer and regulatory requirements. Maintains accurate ingredient information in necessary databases and reviews all formula information to support labeling and technical information as part of the commercialization process.

 

Responsibilities:

  1. Calculates product nutrition and ingredient information for product labels that are in compliance with local and export requirements. Most products are regulated by the USDA, some are regulated by the FDA.
  1. Responsible for obtaining USDA/FSIS label approval, temporary approvals and extensions for U.S. products.
  1. Maintains formula management/nutrition databases with ingredient and formula information.
  2. Creates and maintains product labels and label databases for commercialization process.
  3. Works with Sales and R&D to create labels and approved regulatory components as part of commercialization process for new product while leveraging regulations to help the company be competitive in the marketplace.
  4. Review all product related artwork and ensure it meets food regulatory and internal requirements.
  5. Responsible for the development of mandatory label copy which includes product name, weight statement, ingredient statement, allergen declaration, nutrition facts panel and claims which meet government requirements and standard of identities.  This includes ensuring compliance with all label related health and wellness claims.
  6. Participate in the development of training regarding new/changed labeling regulations, trends, etc. that may impact the Organization’s brands or coordinated brands.
  7. Participate in developing and updating appropriate food labeling policies and procedures as needed.
  8. Responds to nutritional and regulatory technical inquiries for both internal and external customers.
  9. Responds to rapidly changing priorities according to business and customer requests.
  10. Assists in controlling SOP processes for Operations and Quality Assurance.
  11. Supports plant in State/Federal certification process.
  12. Supports plant in government and customer audits.
  13. Assists with plant local, state, and federal site permits.
  14. Uses excellent communication skills and represents the company to both external and internal customers in a professional manner.
  15. Follows GMP, Quality and safety practices.

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

 

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

 

  • Bachelor’s degree from a four-year college or university in Science discipline or related field, and 2-5 years of related experience in FDA, USDA or a combination of food product label regulations or nutritional experience; or equivalent combination of college education and experience in lieu of college degree.
  • Proficient in Microsoft Office Products
  • Strong knowledge of ESHA Genesis.
  • Must have good planning, organizational and execution skills.
  • Ability to meet deadlines and established goals and objectives in a fast-paced environment.
  • Strong attention to detail and accuracy in proof-reading, data entry and managing databases.
  • Ability to work independently and use a project management approach to work including definition of projects, agreeing to milestones, timelines and communicating updates as appropriate.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Excellent verbal and written communication skills.

 

Supervisory Responsibilities:

This position has no supervisory responsibilities.

 

Physical Demands:

The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Frequently required to sit; stand; walk; reach with hands and arms.
  • Specific vision abilities required include close vision, distance, vision, and ability to adjust focus.
  • Occasionally lift and/or move up to 20 pounds.

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • The majority of the time is spent in an office setting outside of the production plant.  The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals.
  • Noise level in the work environment is usually moderate but can be loud when in the production area.