Facility Quality Assurance Manager

Grüns•Roanoke, TX

6d•Onsite

About The Position

Provides overall leadership, ownership, and direction for the Facility Quality Management System (QMS) supporting product quality, food safety, regulatory compliance, and continuous improvement. Ensures facility compliance with applicable regulatory, customer, and certification requirements, including FDA 21 CFR requirements, GMPs, HACCP, SQF/GFSI requirements, and internal company standards. Serves as the facility SQF Practitioner and oversees implementation, maintenance, verification, and continuous improvement of food safety and quality programs. Oversees the Quality Assurance Department and promotes a strong food safety culture and accountability throughout facility operations. This role is onsite at our Roanoke, Texas location.

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.

Nice To Haves

HACCP training/certification
21 CFR training/certification
SQF Practitioner qualification or demonstrated experience

Responsibilities

Owns and maintains the facility Quality Management System (QMS), ensuring food safety and quality programs are effectively implemented, maintained, verified, and continuously improved in accordance with applicable FDA 21 CFR requirements, SQF/GFSI requirements, customer requirements, and company standards.
Serves as the facility SQF Practitioner and maintains the SQF System, including verification activities, program implementation, corrective actions, and continued compliance with certification requirements.
Leads and participates in Management Review, including evaluation of quality and food safety objectives, KPIs, non-conformances, complaints, audit results, CAPAs, verification activities, and opportunities for continuous improvement.
Owns and maintains the facility HACCP Program, ensuring hazard analyses, monitoring, verification, validation, corrective actions, and required records remain current and effective.
Ensures CCP verification activities are completed and documented as required.
Oversees facility QA operational controls, including receiving inspections, packaging and label verification, in-process quality checks, and finished product inspections, ensuring products and materials meet approved specifications and established acceptance criteria.
Reviews and approves Master Manufacturing Records (MMRs), Packaging Batch Records, and completed batch production records, as applicable, to ensure accuracy, completeness, traceability, reconciliation/yield requirements, and compliance with approved procedures and applicable 21 CFR requirements prior to product disposition.
Oversees the control, investigation, and disposition of nonconforming materials, ingredients, packaging components, work-in-process, and finished products, including holds, deviations, investigations, CAPAs, and corrective action requests.
Verifies sanitation effectiveness through review of sanitation records, pre-operational inspections, ATP/environmental monitoring results, and other applicable verification activities; ensures identified deficiencies are appropriately corrected and documented.
Leads and supports SQF/GFSI, FDA/21 CFR, customer, certification, and internal audits, including audit preparation, document readiness, execution, response to findings, corrective actions, and verification of effectiveness.
Maintains audit and regulatory readiness by ensuring food safety and quality procedures, programs, records, and supporting documentation are current, controlled, complete, accurate, and readily retrievable.
Reviews food safety and quality records for accuracy, completeness, compliance, and appropriate documentation, ensuring discrepancies are investigated and resolved when required.
Leads and coordinates traceability exercises and mock recalls, evaluates results against established requirements, documents outcomes, and ensures corrective actions are implemented when deficiencies are identified.
Reviews new products, processes, specifications, and applicable documentation to ensure food safety, quality, regulatory, and customer requirements are appropriately established and implemented.
Manages the facility Food Safety and Quality Training Program, including development, implementation, and maintenance of food safety and quality learning plans and the facility training matrix.
Ensures required training is assigned based on job responsibilities, completed within established timelines, appropriately documented, and maintained current.
Coordinates initial, refresher, and retraining activities and verifies employee competency, as applicable.
Provides training, coaching, and development to QA personnel and supports the qualification and continued competency of HACCP Team members, Internal Audit Team members, and other personnel with assigned food safety and quality responsibilities.
Promotes and supports a strong Food Safety Culture through leadership, employee engagement, training, communication, accountability, performance monitoring, and continuous improvement.
Monitors applicable FDA regulations, SQF/GFSI requirements, and other regulatory or certification changes and ensures relevant facility programs, procedures, and practices are updated as necessary.
Provides Quality and Food Safety performance metrics, trends, significant issues, and improvement opportunities to facility and Quality leadership and escalates issues that may impact product safety, quality, compliance, or release.