Quality Assurance Specialist

4 weeks ago


Aurora, Colorado, United States Medix Full time
Quality Assurance Specialist

At Medix, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring compliance to federal and state laws, as well as GPN standards and specifications.

  • Key Responsibilities:
  • Maintain calibration of quality control equipment.
  • Auditing the assigned area, and communicate quality or compliance concerns with urgency.
  • Perform inspections across all stages of productions such as incoming raw materials and packaging, in-process, final inspection, and returns to ensure products meet specifications.
  • Perform sensory evaluations on in-process and finished product.
  • Support the Distribution Centers and Warehouses process in regards to Finished Goods inspections, SAP transactions and releases.
  • Data entry in Logs pertaining to Quality Metrics.
  • Perform SAP transactions for releases, holds, reworks and High Jump where applicable, and enter results into a computerized system, track and report results (GP/SAP/MS Office programs).
  • Perform cleaning verifications using ATP swabs and visual inspections to approve manufacturing rooms prior to production.
  • Records verification to ensure all production and quality documents are accurately completed in real-time during manufacturing process.
  • Complete written process, SOPs, and SSOPs deviations.
  • Support Validations, Environmental Control Program ECA, Customer Complaints Investigations and Document Control.
  • Prepare and/or collect samples for laboratory testing for Raw Material receipts and Finished Product investigations.
  • Flexibility to perform other duties as assigned.


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