Regulatory Associate

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Active Full Time Lancaster, PA, US

7 days ago Requisition

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 Associate

• Medical
• Dental
• Vision
• FSA
• HSA
• EAP
• 401K
• 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.

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.

• Support regulatory, quality, purchasing, R&D, customer service, and other departments by coordinating documentation, product information, and compliance-related requests.
• Request, review, organize, and maintain supplier, raw material, finished goods, and customer documentation to support supplier approval, ERP set-up, audit readiness, product claims, and regulatory compliance.
• Assist with compliance activities related to food safety, quality systems, allergens, customer requirements, and certification programs, including but not limited to FDA, PA Department of Agriculture, SQF, Kosher, Halal, Organic, Non-GMO Project, and Gluten Free requirements.
• Monitor supplier and ingredient compliance information, including warning letters, import alerts, regulatory updates, and other relevant sources, and assist with supplier and ingredient risk assessments.
• Participate in internal audits, quality system reviews, and audit preparation activities as directed by the Regulatory Supervisor.
• Complete customer surveys, questionnaires, specification requests, and documentation submissions through email, customer portals, supplier portals, or other document management systems.
• Maintain and update supplier, raw material, product, finished good, customer documentation, and ERP information to support accurate specifications, customer notification, and internal alignment.
• Maintain quality, laboratory, regulatory, and EHS manuals and related controlled documents, including updates, routing, distribution, filing, and archiving as needed.
• Assist with laboratory notebook printing, collation, filing, and archiving as necessary.
• Assist with regulatory research for FDA, EU, and non-EU country requirements; maintain third-party regulatory information; and support updates to company regulatory policy documents.
• Support product development, food safety, food quality, continuous improvement, training development, and other cross-functional projects as needed.
• Function as a back-up to other members of the Regulatory Team based on business needs, background, and training.
• Perform other duties as assigned.

• Regulatory Compliance skills and experience preferred.
• 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 interfacing with suppliers and customers on a daily basis and ensuring customer satisfaction.
• Organized and detail-oriented with the ability to maintain documentation.
• Experienced…