Quality Assurance Specialist I

2 weeks ago


Spanish Fork, Utah, United States Aspen Co-Pak LLC Full time
Job Overview

Position Summary

The role of the Quality Assurance Specialist involves a diverse range of responsibilities aimed at the development and upkeep of quality documentation, conducting investigations, providing training, and performing audits. This position is essential for maintaining adherence to the quality management system and demands exceptional organizational skills and meticulous attention to detail.

Key Responsibilities

  • Develops, revises, and manages master manufacturing records (MMRs), as well as batching and production documentation.
  • Establishes, updates, and oversees specifications for finished products, raw materials, and packaging.
  • Supports the maintenance of Standard Operating Procedures (SOPs), forms, work instructions, and other quality-related documents as necessary.
  • Generates deviation reports and manages change control documentation.
  • Evaluates and approves incoming labels according to customer standards or approvals.
  • Organizes, archives, and maintains essential documents and records.
  • Assists in the supplier approval process.
  • Conducts inspections, collects samples, and authorizes the release of incoming materials.
  • Oversees the environmental monitoring program, including sample collection and result tracking.
  • Contributes to the HACCP and Food Safety initiatives.
  • Participates in the implementation and monitoring of plant-wide prerequisite programs.
  • Ensures compliance with Good Manufacturing Practices (GMP) across the facility.
  • Supports the internal auditing process by identifying non-compliance issues and recommending corrective actions to management.
  • Assists in addressing customer complaints, implementing corrective actions, and managing CAPA processes.
  • Facilitates GMP training sessions.
  • Reviews production records, evaluates test results, and oversees the release of finished products.
  • Acts as a backup for the Quality Manager as needed.

Required Qualifications

  • Comprehensive knowledge of Quality Assurance systems, FDA regulations, Good Manufacturing Practices (GMP), HACCP principles, and internal auditing processes.
  • Ability to interpret product quality standards, specifications, and regulatory documentation.
  • Demonstrated teamwork capabilities.
  • Effective and professional communication skills.

Experience and Educational Background

  • A minimum of 5 years of relevant experience, preferably within the food manufacturing sector.
  • PCQI certification is preferred.
  • Bilingual proficiency in English and Spanish is advantageous.
  • HACCP certification is required.
  • Familiarity with NSF, SQF, Organic, Kosher, and Halal certification standards is preferred.


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