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.
4. 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. |