Regulatory and Quality Specialist - Essentia

Bachelor's degree in Applied Sciences, or Associates degree with 1-3 years of regulatory, quality, and/or supplier experience.

Minimum 1-3 years of work experience in a regulatory affairs role, quality systems role, and/or supply quality role, including knowledge of USDA-FSIS Regulations.

• ◆Create and manage regulatory, quality, and supplier documentation as required by internal/external customers, third party organizations, and local government agencies (USDA, FDA, Import/Export, etc.).
• ◆Provide timely and accurate responses to customer documentation inquiries, including product and site questionnaires and other collateral documents.
• ◆Assist with USDA and FDA labeling submissions and follow-up.
• ◆Help research appropriate USDA/FDA regulations and work with Regulatory and Quality Managers to provide feedback to internal and external customers.
• ◆Coordinate Organic-GAP Certifications, including support to manufacturing facilities with documentation needed.
• ◆Maintain corporate controlled documentation, including regulated labeling systems within Colos and Reliance software systems.
• ◆Maintain accurate, up-to-date records, including monthly reporting and regulatory files for Essentia North America.
• ◆Support customer service and supplier quality projects with documentation where needed.
• ◆Assist with processing of professional membership renewals and registrations for Essentia North America.
• ◆Review and manage Harmonized Tariff Schedule codes and create documentation for their selection.
• ◆Perform vendor site assessments to deploy risk management techniques for suppliers. Monitor poor performance or otherwise that negatively impact quality and delivery metrics.
• ◆Perform on-site inspections with warehouse entities where applicable.
• ◆Coordinate with supply chain management on completion of specification and quality agreements with suppliers.
• ◆Reviews and coordinates all aspects of the supplier assessment process.
• ◆Provides updates to supplier records on behalf of account owners.
• ◆Assist corporate supply chain management with supplier data for metrics and risk management documents. This includes audits, complaints, and receiving inspections.
• ◆Coordinate Essentia activities around supplier expectations.
• ◆All other tasks as assigned.

JOB

• ✓Knowledge of organizational methods and ability to work in a fast pace changing environment and manage multiple tasks simultaneously.
• ✓Proficient English skills.
• ✓Knowledge and ability to communicate effectively with corporate staff, manufacturing staff, and Essentia customers.
• ✓Competent in the use of computers and software packages such as MS Word, Excel, PowerPoint, Reliance, MS Teams
• ✓Strong attention to detail.
• ✓Ability to communicate and interact in a professional manner that upholds the Essentia Values.
• ✓Ability to work daily and extended hours as needed.
• ✓Ability to assist with special and ongoing projects as determined by leadership.
• ✓Ability to provide assistance in other work-related areas as required.
• ✓Ability to work with international trade of food and/or regulated feed, fertilizer and petfood ingredients (IDALS, AAFCO, APHIS, CFIA etc.).
• ✓Raises vital questions and problems, formulation them clearly and precisely
• ✓Gathers and assesses relevant information, using abstract ideas to interpret it effectively comes to well-reasoned conclusions and solutions, testing them against relevant criteria and standards
• ✓Travel up to 25%.