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Senior Manufacturing Quality Assurance Specialist in Minneapolis, MN for Fairview Health Services
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Senior Manufacturing Quality Assurance Specialist
Overview This position is a quality assurance compliance role which supports IntegraDose operations and production by ensuring that quality systems and manufacturing operations are compliant with the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act. Responsibilities/Job Description Collaborate with the Manufacturing Quality Assurance Program Manager to implement and maintain the IntegraDose quality management system (QMS). Establish, implement, maintain, and manage quality management system (QMS) functions including; documentation control, change control, equipment management, environmental monitoring, auditing, root cause analysis, and CAPA. Take ownership a


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