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Quality Specialist I

3 months ago

Spanish Fork, United States Aspen Co-Pak LLC Full time
Job DescriptionJob Description

Job Summary

The Quality specialist role encompasses a variety of tasks including creation and maintenance of quality documents, investigations, training, and audits, and helps ensure compliance to the quality system. This position requires a high level of organization and attention to detail.

Job Duties

  • Creates, updates, and maintains master manufacturing records (MMR’s), batching and production records
  • Creates, updates, and maintains finished product specifications, raw material specifications and packaging specifications
  • Assists 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 standard or customer approval
  • Organizes, files, and maintains documents and records as needed
  • Assists with supplier approval program
  • Inspects, pulls samples, and releases incoming materials
  • Manages environmental monitoring program (pulls samples, reviews and tracks results
  • Assists with responsibilities for HACCP and Food Safety programs
  • Participates in ensuring plant wide Pre-requisite programs are instituted and functioning
  • Helps to ensure plant wide GMP compliance
  • Assists in internal auditing program. Assesses non-compliances and makes recommendations for corrective actions to management
  • Assists with customer complaints, corrective actions and CAPA’s
  • Assists with GMP training
  • Assists with review of production records, test result review and finished product release
  • Back up to Quality manager

Required Skills

  • Knowledge of Quality Assurance systems and procedures, FDA, Good Manufacturing Practices (GMP’s), 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

Experience and Education

  • 5 years minimum work experience in related field (preferably in food manufacturing)
  • PCQI trained (preferred)
  • Bilingual in English and Spanish (preferred)
  • HACCP trained
  • Experience with NSF, SQF, Organic, Kosher, Halal certification requirements (preferred)