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Quality Assurance Manager

2 months ago


Schaumburg, United States Blind Ad Full time $50,000 - $100,000
Job DescriptionJob Description

About the Job:

Day to day operations

  • Sample all incoming materials according to establish sampling plans and arrange timely testing by approved Third party Laboratories.
  • Perform incoming visual ID testing of Commodity Printed Specifications and Non-Commodity Printed Specifications
  • Approve and issue blank BPR’s to production
  • Ensure applicable production procedures and BPR are followed
  • Confirm work orders are properly dispensed
  • Confirm line-clearance activities
  • Dispense fully approved printed commodities to production
  • Ensure in-process QC checks are performed and that required representative samples are collected
  • Ensure any failures to meet in-process and finished specifications
  • Ensure that any deviations or EE’s are documented
  • Confirm that every BPR is an accurate representation of the Master Batch Record (MBR)
  • Confirm that all cGMP’s are properly documented
  • Complete batch record review checklists
  • Follow the record retention policy to ensure that production records are maintained

Qualifications

  • Deep understanding of FDA’s 21 CFR 111 regulations on Dietary Supplements, FSMA (food safety modernization act) and HACCP (hazard analysis critical control points)
  • Have experience working with MS Word, Excel and Outlook
  • Solid communication skills
  • Experience in change control and general technical knowledge of testing desired
  • Able to occasionally lift a maximum of 50Ibs with assistance
  • Fluent in English
  • Not required but greatly desired if the individual is fluent or able to speak some Spanish
  • Not required but beneficial if applicant if applicant has a science, biology or engineering degree