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Quality Assurance Specialist

2 months ago

Decatur, Illinois, United States Fagron Full time
Job Title: Quality Assurance Technician II

Job Summary:

The Quality Assurance Technician II will be primarily responsible for ensuring the quality of bulk release processes, including test requirement determination, bulk dispositioning, and receiving document review. This role will also support finished good and label release processes, and Letco Certificate of Analysis approvals.

Key Responsibilities:
  • Provides bulk receipt disposition notifications.
  • Performs physical inspections of bulk containers and disposition labeling.
  • Maintains Manufacturer Certificate of Analysis document files.
  • Creates test sample labels as required.
  • Determines test requirements of bulk, reviews test results, and completes applicable test sample documentation.
  • Performs bulk sampling, including staging.
  • Reviews Manufacturer Certificate of Analysis against applicable compendia monograph and associated receiving documents for accuracy.
  • Performs in-house identification testing using a TruScan RM Spectrometer.
  • Performs inspection and disposition of direct-to-stock chemicals.
  • Performs inspections, tests, and disposition of container/closure repack components.
  • Reviews Letco labels for accuracy and approval.
  • Creates or reviews and approves Letco Certificates of Analysis.
  • Assists with inspection and disposition of item returns.
  • Assists with organization of the document control storage room and server files.
  • Performs facility and health check audits and reports results as required.
  • Performs initial investigations for customer and supplier complaints as assigned.
  • Assists in investigations of internal quality issues as required.
  • Provides quality support to Production, including production event assessment, item inspections, room inspections, etc. as needed.
  • Performs QA Sample Room housekeeping or inspections for cleanliness as required.
  • Documents quality assessments and finding reviews for complaint investigations, including creation of customer response letters for approval, as assigned.
  • Reviews for disposition of blank media label receipts.
  • Serves as a primary backup support for the Quality Assurance Technician I.
  • Assists with finished goods release process, including batch record and record disposition, maintenance of retain sample program, and inspection of finished good units.
Requirements:
  • High School Diploma or GED equivalent required; Associate Degree or Bachelor's Degree in a science-related field or industry equivalent experience preferred; minimum of two (2) years of progressive responsibilities in quality assurance/control experience preferred; or an equivalent combination of education and experience.
  • Experience in the pharmaceutical industry a plus.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to work with mathematical concepts such as probability and statistical inference and apply the concepts to practical situations.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Proficient in the Microsoft Office suite of applications including Word, Excel, PowerPoint, and Outlook, and with Internet Explorer.
What We Offer:

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.