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Quality Assurance Associate

2 months ago

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

Position Summary

The role of the Quality Specialist involves a range of responsibilities aimed at ensuring the integrity of quality documentation, conducting investigations, providing training, and performing audits. This position demands exceptional organizational skills and meticulous attention to detail.

Key Responsibilities

  • Develops, revises, and sustains master manufacturing records (MMRs), as well as batching and production documentation.
  • Formulates, updates, and oversees specifications for finished products, raw materials, and packaging.
  • Assists in the upkeep 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 in accordance with customer standards or approvals.
  • Organizes, archives, and maintains essential documents and records.
  • Supports 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 management of 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.
  • Assists in the internal auditing process, identifying non-compliance issues and recommending corrective actions to management.
  • Supports the resolution of customer complaints and the development of corrective actions and CAPA plans.
  • Facilitates GMP training sessions.
  • Assists in the review of production records, test results, and the release of finished products.
  • Acts as a backup for the Quality Manager.

Required Qualifications

  • Familiarity with Quality Assurance systems, FDA regulations, Good Manufacturing Practices (GMP), HACCP, and internal auditing processes.
  • Ability to comprehend and interpret product quality standards, specifications, and regulatory documentation.
  • Team-oriented with strong collaborative skills.
  • Effective and professional communication abilities.

Experience and Education Requirements

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