About This Role

Apeel Sciences is seeking a conscientious and detail-oriented Regulatory & Quality Assurance Specialist to support our product operations and our adherence to Good Manufacturing Practices (GMPs) for our products. The ideal candidate can interpret regulations from domestic and international regulatory authorities and be able to apply the principles to Apeel’s facilities and processes. The person in this role will collaborate closely with other teams at Apeel to ensure compliance in all our operations. This position would be most suitable to an individual who enjoys a dynamic, collaborative environment, takes pride in taking accurate work to completion, and is constantly seeking ways to solve problems and drive business results.

What You’ll Do

• Develop an intimate and hands-on understanding of Apeel’s business activities and processes, which includes, but are not limited to product development, manufacturing, quality control, and warehousing/logistics
• Maintain up-to-date knowledge of all applicable regulations, including the FDA Food Safety Modernization Act (FSMA), guidance documents, and other agency regulations, as appropriate
• Assist with regulatory assessments and support work needed to obtain regulatory clearance and/or import authorization in new markets and maintain access to existing markets
• Review records for accuracy and completion in compliance with GMPs and GDPs to facilitate product releases
• Work closely with Facilities, Supply Chain, Manufacturing, Business Units, or other teams to ensure compliance with GMPs at all Apeel facilities
• Generate or update Standard Operating Procedures, Forms, and other controlled documents in compliance with applicable regulations
• Perform Document Control tasks such as document implementation, scanning, filing, etc.
• Manage workflows for internal processes and share/implement ideas for continuous improvement of these processes
• Interact with government agencies (local, state, and federal) as needed
• Create guidance documents for internal use and customers
• Proactively identify areas for improvement at Apeel, and implement processes that help to advance our operations

What You Bring

• Experience working in an FDA-regulated industry (food industry is preferred)
• Knowledge of Good Manufacturing Practices (GMP) and Enterprise Resource Planning (ERP) systems
• Some knowledge of food additive and/or crop protection regulatory framework preferred
• Passion for building new processes
• Curiosity and comfort in exploring new ways of looking at challenges
• Extreme attention to detail while working with a healthy sense of urgency to maintain momentum on business priorities
• Excellent technical writing skills
• Strong interpersonal skills
• Strong verbal communication skills
• Proficiency using Google Suite & Microsoft Office programs; experience with task management software is a plus
• Ability to thrive in a fast-paced environment
• Ability to work with minimal supervision
• Highly organized and with a strong ability to manage multiple priorities in parallel with each other
• Highly committed to collaborative teamwork
• Strong critical thinking and problem-solving skills