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Salary: USD 100,000 - 110,000 / annual
Grüns is a nutrition company focused on comprehensive, whole-food-based gummy supplements. This role provides overall leadership and ownership of the facility's Quality Management System (QMS), ensuring product quality, food safety, regulatory compliance, and continuous improvement across all operations.
Key Responsibilities:
- Own and maintain the facility QMS, ensuring food safety and quality programs comply with FDA 21 CFR requirements, SQF/GFSI standards, customer requirements, and company standards
- Serve as the facility SQF Practitioner, maintaining the SQF System including verification activities, program implementation, corrective actions, and certification compliance
- Lead Management Review activities, evaluating quality and food safety objectives, KPIs, non-conformances, complaints, audit results, CAPAs, and continuous improvement opportunities
- Own and maintain the facility HACCP Program, ensuring hazard analyses, monitoring, verification, validation, corrective actions, and required records remain current and effective
- Oversee facility QA operational controls including receiving inspections, packaging and label verification, in-process quality checks, and finished product inspections
- Review and approve Master Manufacturing Records (MMRs), Packaging Batch Records, and completed batch production records for accuracy, completeness, traceability, and compliance
- Oversee control, investigation, and disposition of nonconforming materials, ingredients, packaging components, work-in-process, and finished products
- Verify sanitation effectiveness through review of sanitation records, pre-operational inspections, ATP/environmental monitoring results, and other verification activities
- Lead and support SQF/GFSI, FDA/21 CFR, customer, certification, and internal audits, including preparation, execution, findings response, and corrective action verification
- Maintain audit and regulatory readiness by ensuring food safety and quality procedures, programs, records, and documentation are current, controlled, complete, accurate, and readily retrievable
- Review food safety and quality records for accuracy, completeness, and compliance; investigate and resolve discrepancies
- Lead and coordinate traceability exercises and mock recalls, evaluating results and implementing corrective actions when deficiencies are identified
- Review new products, processes, and specifications to ensure food safety, quality, regulatory, and customer requirements are appropriately established and implemented
- Manage the facility Food Safety and Quality Training Program, including development, implementation, and maintenance of learning plans and training matrices
- Provide training, coaching, and development to QA personnel and support qualification and competency of HACCP Team members, Internal Audit Team members, and other personnel with food safety and quality responsibilities
- Promote and support a strong Food Safety Culture through leadership, employee engagement, training, communication, accountability, performance monitoring, and continuous improvement
- Monitor applicable FDA regulations, SQF/GFSI requirements, and other regulatory or certification changes; ensure relevant facility programs, procedures, and practices are updated
- Provide Quality and Food Safety performance metrics, trends, significant issues, and improvement opportunities to facility and Quality leadership; escalate issues that may impact product safety, quality, compliance, or release
Requirements:
- Demonstrated knowledge and experience with FDA regulations applicable to food and dietary supplement operations, including 21 CFR Part 111 and applicable Current Good Manufacturing Practices (cGMPs)
- SQF Practitioner experience required, with demonstrated knowledge of SQF/GFSI requirements and implementation and maintenance of an SQF System
- Demonstrated knowledge and practical experience with HACCP programs, including CCP monitoring and verification
- Experience managing or supporting a facility Quality Management System (QMS), including document control, records review, CAPA, internal audits, management review, traceability, and mock recalls
- Experience with food safety and quality activities within packaging, labeling, receiving, in-process operations, sanitation verification, and finished product inspection
- Experience supporting and/or leading regulatory, customer, GFSI/SQF, and internal audits
- Dietary supplement manufacturing, packaging, or distribution experience
- Bilingual English/Spanish required, with the ability to communicate effectively in both languages with employees at all levels of the organization
- Bachelor's degree with 7+ years related experience or equivalent combination of education and technical work experience
- Preferred/Required Certifications: HACCP training/certification, 21 CFR training/certification, and SQF Practitioner qualification or demonstrated experience
