Food Safety and Quality Specialist

Regulatory Compliance Specialist

In this role, you will be responsible for supporting regulatory compliance programs and initiatives, focusing on FDA regulations as they pertain to food safety and quality, including private label food products. You will assist management in food product reviews, audit information and system standards by researching and analyzing data, preparing reports, conducting risk assessments, enforcing corrective action where necessary, and record keeping. You will collaborate with various parts of the business, including Merchandising, Legal and Risk. This is a great opportunity for a motivated candidate to enhance the breadth and depth of their technical compliance skills, to be part of a high-performing team, and to gain exposure to the operations of numerous product lines.

Specific responsibilities include but are not limited to:

• Assist in the administration of quality system processes, including but not limited to product disposition, oversight of vendors and foreign suppliers, product and/or purchasing specifications, external audits, significant deviation investigation review, labels/labeling control, warehousing, and distribution in compliance with FDA regulations and guidance, including Good Manufacturing Practices and FSVP requirements under FSMA.
• Support in the assessment of vendors, manufacturers, laboratories, and/or materials to confirm their suitability and competence to execute pre-defined activities (e.g., through audits, material evaluations, qualification).
• Assist in triaging product complaints, returns, discrepancies/deviations, CAPAs, trending analysis, and completion of controlled documents including for food and pet food products.
• Lead efforts to ensure consistency across the company with regulatory process documentation and documentation management.
• Maintain positive and cooperative internal relationships and collaboratively works to resolve any issues or discrepancies with regulatory records or product requirements.
• Help manage, monitor, and document product recalls and withdrawals.
• Proactively research solutions when internal quality issues arise and bring potential resolutions to leadership when escalating issues.
• Maintain third-party certification records and other confidential documents which will include direct communication with vendors.
• Enter, maintain, and organize key compliance documents in electronic document management systems.
• Manage training records, schedules and associated supplemental materials.
• Help with the regulatory notification process and manage regulatory agency interactions.
• Assist in the development of regulatory and quality assurance strategies.
• Act independently to determine and coordinate methods and procedures on new assignments.
• Assist with internal and external regulatory audits as needed.
• Support special projects and perform additional duties as assigned.

Minimum Requirements/Qualifications:

• Minimum of 2 years of experience in a business environment.
• Ability to work independently and as part of a team.
• Strong interpersonal skills.
• Excellent attention to detail and organizational skills.
• Ability to analyze problems and suggest creative solutions.
• A strong aptitude for proofreading and identifying discrepancies in documents.
• Ability to multi-task in a fast-paced environment and work under deadlines while maintaining a high level of accuracy.
• Self-motivated and able to use risk-based approach for prioritization of activities.
• Ability to learn and apply technical and scientific concepts.
• Appreciation for procedures and the maintenance high-quality work processes.
• Confident and professional communicator with the ability to adhere to confidentiality standards.
• Ability to write clear, understandable technical documentation, e.g., regulatory documentation or scientific presentations.
• Highly proficient in Microsoft Office and database management.

Preferred Qualifications:

• Education: Bachelor's Degree or higher, especially in Food Safety, Food Science, Biology, Microbiology, Chemistry, Risk, Compliance, or similar fields.
• Professional Experience: 2-7 years.
• Prior experience with FDA-regulated products including but not limited to food, dietary supplements, pet food, and pharmaceuticals.
• High level of comfort with learning and implementing processes within new electronic systems and managing large quantities of data and documentation.
• Interest in gaining subject matter expertise in food safety and quality.