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QA Specialist

Company Name:
Professional Search Centre, Ltd.
Just took on an awesome search for a QA Specialist for our client based near Chicago, IL. The QA Specialist functions as the front-line of Quality Assurance. Main responsibilities include quality activities (NMR, CAPA, Change Control), tracking training records, document control and release, and providing support to Regulatory Affairs. Reporting to the Associate Director of RA / QA, some additional tasks include:
Review and approve validation protocols and reports.
Quality review of batch records, analytical data, manufacturing/packaging deviations and investigations
Issue and control of Certificates of Analysis
Document Control/Quality System maintenance and support
Responsible for Change Control, NMR, CAPA, SCAR databases and trending
Assist with Annual Product Reviews, Management Reviews, and Annual Product Report preparation
Process complaints and assist with MDR and pharmacovigilance activities.
Participate in audits
Must have general knowledge of drug and device quality regulations; ISO 13485/14971 and ICH standards; thorough understanding of sterile manufacturing processes and operations; and, Bachelor's Degree in some related field.

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