Hybrid Regulatory Coordinator at Shank’s Extracts, LLC d/b/a Universal Ingredients

Shank’s Extracts, LLC d/b/a Universal Ingredients – Shank’s is a premier manufacturer of vanilla extracts, other extracts, natural and artificial flavors, food colors, syrups, and sauces. Shank’s quality products are widely distributed to industrial, private-label, and grocery customers worldwide. We have an immediate opening for a Regulatory Coordinator

Available Immediately Upon Hire: Medical, Dental, Vision, FSA, HSA, EAP, ID Theft, 401K, and PTO.

Disclaimer: Shank’s Extracts manufactures various products that identify as major food allergens (milk, eggs, tree nuts, wheat, and soybeans) as well as several other food ingredients. We cannot guarantee you will not be exposed to skin and/or odor contact with these various ingredients. Your health and safety are our number one priority, and we will do our best to accommodate within reason.

ESSENTIAL FUNCTION: 

The primary purpose of this position is to support compliance with government and customer regulations and policies and to assure preparedness for various audits and inspections.  Additional responsibilities are to maintain, monitor and distribute company information in the areas of raw material and finished goods documentation, standard operating procedures, and food safety policies and practices; and to support the Quality Assurance functions.  This role is also required to back up the Quality Systems Regulatory Supervisor as needed.

DUTIES AND RESPONSIBILITIES:

• Work with Quality Assurance, Purchasing, R&D, Customer Service, and other departments, as needed.
• Assist with requesting and maintaining supplier documentation for:
  • Compliance with our Supplier Approval and other internal Quality System Programs, including but not limited to Allergen Management.
  • Accurate part set-up in the ERP
  • Compliance with various auditing and certification bodies, including but not limited to FDA, PA Dept of Ag, SQF, Kosher (Orthodox Union), Halal (ISA), Organic (QAI), NGMO Project (Food Chain ID), and Gluten Free (NSF).
  • Customer documentation requests, product claim substantiation, international regulation compliance, etc.
• Monitor supplier warning letters, import alerts, etc. via searches on other software and/or federal websites.
• Risk assesses suppliers and ingredients
• Lead and/or participate in food safety and quality-based internal audits.
• Audit Quality Systems as necessary or as directed by the Regulatory Supervisor.
• Assist with inspectors and auditors as appropriate.
• Assist in maintaining Identity Preserved Foods (IPF) certifications and partake in IPF audits.
• Complete customer surveys/questionnaires/requests via e-mail, fax, and/or customer or supplier document management portals.
• Respond to customers’ technical regulatory questions.
• Update customer documentation and coordinate alignment and ERP specifications and aid in customer notification as necessary.
• Work intra and interdepartmentally on projects to support product development, food safety, food quality, and continuous improvement for the organization.
• Set-up and maintain all suppliers, raw materials, products, and finished goods in the ERP and/or other software
• Train new hires and current employees via 1-pt refresher training
• Complete trace exercise for raw materials, liquids, finished goods, and food contact packaging as needed or as directed by the Regulatory Supervisor.
• In addition to the Regulatory Supervisor, determine final levels of ingredients of concern in raw materials and corresponding finished products.
• In addition to the Regulatory Supervisor, review customer labels for FDA compliance, claim substantiation, etc.
• In addition to the Regulatory Supervisor, assist in researching regulations as needed for FDA, EU, and Non-EU country requirements. Coordinate requests within the organization as appropriate and manage 3^rd party regulatory company information. 
• Under the direction of the Regulatory Supervisor and in conjunction with the Regulatory Team review and update Shank’s regulatory policy documents as appropriate.
• Keep up to date with Regulatory changes affecting Shank’s products and operations.
• In addition to the Regulatory Supervisor, primary researcher of regulations as needed for FDA, EU, and Non-EU country requirements. Coordinate requests within the organization as appropriate and manage 3^rd party regulatory company information. 
• Function as back-up to other members of the Regulatory Team, and/or Regulatory Supervisor, pursuant to business needs and background/training.
• Perform other duties as assigned. 

ESSENTIAL/SKILLS NEEDED:

• Regulatory Compliance skills and experience required.
• Strong computer skills with the ability to create spreadsheets using Excel, and excellent MS Word skills.
• Familiarity with ERP/Manufacturing computerized systems.
• Excellent written and verbal English communication skills.
• Excellent customer service skills with experience in interfacing with suppliers and customers on a daily basis and ensuring customer satisfaction.
• Organized and detail-oriented with the ability to maintain documentation.
• Experienced working within a team yet able to work independently, completing work on a timely basis, and self-motivated.
• PA Driver’s license with a clean driving record to be able to drive own car or company vehicle to designated locations.

EDUCATION AND EXPERIENCE

• Food Science, Chemistry, Regulatory Affairs, Quality Assurance, or similar BS Preferred. 
• 3 years or more in a Quality Assurance role for the food industry required.
• Specialized training in compliance with requirements for the food industry is required.
•   HACCP certified is preferred, otherwise, required to become HACCP certified within the first six months.
•   PCQI and/or FDQI and/or FSVP-QI a plus.

PHYSICAL REQUIREMENTS:

• Operates computer.
• Sits the majority of the time but occasionally walks through the plant for internal and external audits. 
• Seldom exposure to noise and poor ventilation.   Occasionally exposed to dust, odor, and fumes.  Frequent exposure to chemicals. Light work requires little physical effort.
• Exposure to food allergens such as, but not limited to, milk eggs, tree nuts, wheat, and soybeans will occur.

Conduct, Quality, Integrity, and Culture

Conduct: We will conduct every aspect of our business with honesty, integrity, and openness, respecting human rights and the interests of our employees, customers, and third parties.

Quality: Shank’s is committed to food safety and product quality. We employ extensive food safety programs and controls at all levels. Our quality standards and food safety procedures are thoroughly being evaluated internally and externally. We continuously strive to improve our performance.

Integrity: Shank’s and its employees will not offer, give, seek or receive, either directly or indirectly, improper inducements for business or financial gain. Where information is confidential, that confidentiality must be protected.

Culture: Shank’s respects the cultural values of our employees, contractors, and customers. We also promote a balanced work-life environment. We recognize and celebrate our employees for their hard work and the contributions they make to our company.

Shanks Core Values:

ASPIRATION: Share a vision for achievement 

ACCOUNTABILITY: Support company reputation 

ADAPTABILITY: Evolve to meet business needs

 ***Competitive compensation and benefits package***

Shank’s Extracts, LLC d/b/a Universal Ingredients – Shank’s is an Equal Employment Opportunity/Affirmative Action (EEO/AA) Employer.