Quality Assurance Specialist

4 days ago


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

Job Description:

We are seeking a Quality Assurance Specialist to join our team at Aspen Co-Pak LLC. This role encompasses creating and maintaining quality documents, conducting investigations, training, audits, and ensuring compliance with the quality system.

Key Responsibilities:

  • Create, update, and maintain master manufacturing records (MMRs), batching and production records
  • Create, update, and maintain finished product specifications, raw material specifications, and packaging specifications
  • Assist in maintaining SOPs, forms, work instructions, and other quality documents as needed
  • Creates deviations and change control records
  • Reviews and approves incoming labels based on customer standards or customer approval
  • Organize, file, and maintain documents and records as needed
  • Assist with supplier approval program
  • Inspect, pull samples, and release incoming materials
  • Manage environmental monitoring program (pull samples, review, and track results)
  • Assist with HACCP and food safety programs
  • Participate in ensuring plant-wide pre-requisite programs are instituted and functioning
  • Help ensure plant-wide GMP compliance
  • Assist in internal auditing program; assess non-compliances and make recommendations for corrective actions to management
  • Assist with customer complaints, corrective actions, and CAPAs
  • Assist with GMP training
  • Assist with review of production records, test result review, and finished product release
  • Backup to Quality manager

Requirements:

  • Knowledge of Quality Assurance systems and procedures, FDA, Good Manufacturing Practices (GMPs), HACCP, and internal auditing
  • Ability to understand and interpret product quality, specifications, and regulatory documents
  • Work as a team player
  • Ability to communicate effectively and professionally

Benefits:

  • Competitive salary: $65,000 - $80,000 per year
  • Opportunity for professional growth and development
  • Collaborative and dynamic work environment


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