Quality Assurance Specialist I

Summary

The Quality Assurance Specialist I will coordinate the management of customer inquiries, complaints, CAPAs, and SCARs. This position will assist with supplier approval, internal auditing, quality training, and other quality assurance activities.

Essential Duties and Responsibilities

• CAPA/SCARs
  • Manage and maintain CAPA (Corrective and Preventive Action) and SCAR (Supplier Corrective Action Request) documentation, including forms, logs, reports, and trend analyses.
    • Draft and submit non-conformance response letters to customers in a timely and accurate manner.
    • Serve as a liaison between the company, customers, and suppliers to facilitate investigations and ensure clear communication.
    • Support internal investigations in collaboration with department leads to identify root causes and corrective actions.
    • Ensure the effectiveness and sustainability of corrective and preventive actions to prevent recurrence.
    • Present investigation outcomes and CAPA/SCAR status updates during monthly quality meetings.
    • Act as a backup for the RMA Coordinator, assisting with the processing of product returns.
    • Maintain and update CAPA/SCAR tracking systems to ensure timely resolution and closure of actions.
    • Collaborate with cross-functional teams to implement long-term solutions and drive continuous improvement.
    • Prepare and organize documentation for audits and regulatory inspections related to CAPA/SCAR processes.
    • Monitor non-conformance trends to identify systemic issues and recommend process improvements.
    • Analyze CAPA/SCAR data to support continuous improvement initiatives and enhance operational efficiency.
    • Train team members on proper documentation practices and investigation methodologies related to CAPA/SCAR processes.
  • Vendor Approval
    • Review vendor documentation, including HACCP plans, food safety certifications (GFSI schemes such as SQF, BRCGS, FSSC 22000), third-party audit reports, allergen controls, and process flow diagrams.
    • Evaluate supplier compliance with FDA regulations, FSMA requirements, and company food safety standards.
    • Cook up cross-functional review with Procurement, R&D, Regulatory Affairs, and Operations to approve or reject vendors.
    • Maintain accurate vendor data and approval status in the company’s QA or ERP systems.
    • Verify suppliers follow Good Manufacturing Practices (GMPs), sanitation controls, allergen management, and preventive controls as required under FSMA.
    • Ensure all required documents (e.g., allergen statements, Country of Origin, Organic certifications, Halal/Kosher certificates) are current and properly validated.
    • Conduct risk assessments for new and existing vendors, including foreign supplier verification (FSVP) when applicable.
    • Monitor and follow up on expired or missing vendor documentation.
    • Work with suppliers to resolve quality issues and strengthen food safety systems.
    • Continuously improve vendor approval procedures to align with GFSI scheme expectations and company standards.
    • Participate in food safety team meetings and support ongoing HACCP, HARPC, and risk assessments.
    • Standardize documentation templates, workflows, and review procedures for vendor management.
    • Train Purchasing and other departments on vendor approval processes and requirements.
  • Quality Assurance
    • Conduct monthly GMP (Good Manufacturing Practices) inspections across production and warehouse areas.
    • Absorb assistance with traceability exercises and vertical audits to ensure product integrity and compliance.
    • Participate in ingredient and supplier risk assessments to support procurement and quality decisions.
    • Coordinate and track monthly quality training sessions for staff.
    • Review and approve production batch records to ensure compliance with GMP standards.
    • Perform internal audits to verify adherence to established quality policies and procedures.
    • Cook up support validation activities for equipment, manufacturing processes, and cleaning protocols.
    • Review and update Standard Operating Procedures (SOPs) and work instructions to reflect current practices and regulatory requirements.
    • Absorb assistance in managing customer complaints, including investigation and implementation of corrective actions.
    • Maintain calibration and maintenance records for equipment critical to quality assurance.

Qualifications

• Associate's degree (A. A.) or equivalent from a two-year college or university in a scientific discipline with 1- 3 years related experience and/or training, or Bachelor’s degree (B.S.) or equivalent from a four-year college or university in a scientific discipline.
• 1+ years of food manufacturing experience preferred.
• Excellent verbal and written communication skills.
• Excellent attention to detail.
• Strong team collaboration.
• Strong analytical and problem-solving skills.
• Advanced skills in Microsoft Office (Word, Excel, and PowerPoint).
• Self-motivated with strong time-management skills.

Work Conditions & Physical Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Ability to lift up to 10 lbs.
• Work environment is normally in an office setting.
• Must be able to make frequent rounds in a warehouse/production environment.
• Ability to view a computer screen and type for extended hours.
• Ability to sit and stand for extended periods of time.
• Other physical requirements include moderate standing and occasional squatting, bending, and twisting.
• Must be able to wear any required PPE such as scrubs, hair net, lab coat, and facemask.
• Ability to work around a variety of different smells and aromas.
• Ability to adjust work schedule as business needs require.

Quality/Safety Responsibilities

• All Prinova employees are required to ensure compliance standards with food safety, food defense, and food quality (FDA, ILDPH, FSMA, and BRC).
• It is the responsibility of each employee to comply with occupational safety and health standards issued under OSHA and to follow all rules, regulations, and procedures established by the Company to ensure that their actions do not impact the health and safety of themselves or others.