Quality Assurance Technician II
1 day ago
We are seeking a highly skilled Quality Assurance Technician II to join our team at Fagron. As a key member of our quality assurance department, you will be responsible for ensuring the quality of our products and processes.
Key Responsibilities:- Perform bulk receipt disposition notifications and physical inspections of bulk containers and disposition labeling.
- Maintain Manufacturer Certificate of Analysis document files and create test sample labels as required.
- Determine test requirements of bulk, review test results, and complete applicable test sample documentation.
- Perform bulk sampling, including staging, and review Manufacturer Certificate of Analysis against applicable compendia monograph and associated receiving documents for accuracy.
- Perform in-house identification testing using a TruScan RM Spectrometer and inspect and disposition of direct-to-stock chemicals.
- Review Letco labels for accuracy and approval and create or review and approve Letco Certificates of Analysis.
- Assist with inspection and disposition of item returns and organization of the document control storage room and server files.
- Perform facility and health check audits and report results as required and assist in investigations of internal quality issues as needed.
- Provide quality support to Production, including production event assessment, item inspections, room inspections, etc. as needed.
- Document quality assessments and findings reviews for complaint investigations, including creation of customer response letters for approval, as assigned.
- Review for disposition of blank media label receipts and serve as a primary backup support for the Quality Assurance Technician I.
- Assist with finished goods release process, including batch record and record disposition, maintenance of retain sample program, and inspection of finished good units.
- 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.
- Experience in the pharmaceutical industry a plus.
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.
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