Quality Assurance Coordinator

Department: 812

• Regulatory Compliance Reports To: Senior QA and Regulatory Compliance Manager JOB DESCRIPTION Position Summary: Quality Assurance coordinator is responsible for maintaining product quality and compliance by ensuring adherence to established quality procedures. This position involves daily, weekly, monthly, and as-needed tasks to support the overall quality management system, including documentation review, on-the-floor monitoring, and various special projects. Primary Responsibilities

1. Returns Processing & Reporting: Review return forms to determine the appropriate disposition of returned products. Accurately record all product returns in a dedicated spreadsheet for tracking and analysis. Compile and update the comprehensive monthly return report, providing insights into return trends and volumes. Complete detailed return forms specifically for retailer returns, ensuring all necessary information is captured.
2. Customer Complaint Handling & Investigation: Serve as a primary point of contact for handling product complaints, which includes: Completing detailed complaint forms. Reviewing relevant batch records to identify any deviations. Examining retention samples pertinent to the complaint. Collaborating with relevant staff to review findings and determine root causes and corrective actions. Maintain the quarterly complaint report, summarizing complaint data and trends.
3. Master Manufacturing Record (MMR) Review: Review and sign off on updated or new Master Manufacturing Records (MMRs) to ensure accuracy and compliance with current standards. Create or update MMRs when needed.
4. Organoleptic Review: Perform and document organoleptic review of raw materials to ensure adherence to specifications.
5. Documentation & Archiving: Create and update detailed specification sheets for components, ensuring all critical information is accurately documented. Review, organize, and archive finished or canceled job jackets, maintaining a systematic record-keeping system. Secondary Responsibilities Quality Monitoring & Verification: Perform on-the-floor monitoring activities across various production areas to ensure adherence to quality standards and procedures. Conduct sampling for Cleaning Verification in all relevant departments to confirm effective cleaning processes. Batch Record Review & Release (Coverage): Provide coverage for the batch record review process, which includes thoroughly reviewing batch records and releasing finished products, ensuring they meet all quality and release criteria. Miscellaneous Projects: Participate in and contribute to various special projects related to quality improvement, process optimization, or new product introductions, as assigned.
6. Support Label Management & Verification: Conduct visual inspections of labels for print quality, legibility, damage, and correct information. Assist in reviewing and verifying the accuracy of pre-press proofs and new/revised label artworks against approved specifications and regulatory requirements (e.g., FDA 21 CFR 101 for food labeling, DSHEA). Perform thorough reviews of finished product labels from printing to ensure accuracy, quality, and compliance with specifications. Work Experience Requirements: The candidate must be legally authorized to work in the United States. High school diploma or equivalent Language proficiency – Proficiency in English is required. Proficiency in Spanish is preferred. Computer skills – Possess good computer skills and competence in using Microsoft Office applications. Communication skills – Demonstrate strong communication (verbal, written, presentation) skills. Task Management – Works in coordination with assigned project plans and goals. Attention to detail – Ability to perform routine tasks by ensuring quality parameters are consistently followed and deviation from SOPs are addressed or reported. Physical Requirements: Able to work in an environment that is exposed to powders, chemicals, food allergens, and other potentially sensitizing substances.