Senior Quality Assurance Auditor
- Supervise the following areas in the Quality Assurance department: Internal/External Audits; CAPA, Deviations, Complaints, and NonConformances; and Inventory Control/Quality Control and Labeling.
- Perform internal and external audits and responsible for regulatory licenses and FDA inspections.
- Worked and assisted in the implementation of different quality systems (Label Control, Vendor qualification, Training, Internal Audits, product final inspection among a few). Conduct investigations for deviations, nonconformances and complaints. Supervised the Document Control area.
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Quality Assurance Auditor
- Monitored calls to ensure that what was said in the conversation was what was on the insurance applications. Completed score cards informing agents superiors of the agents strengths and weaknesses. Little or no micromanagement.
- Review and approve quality plans submitted by contractors.
- Generate and maintain quality control operating budgets.
- Verify that raw materials, purchased parts or components, in-process samples, and finished products meet established testing and inspection standards.
- Review quality documentation necessary for regulatory submissions and inspections.
- Review and update standard operating procedures or quality assurance manuals.
- Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends.
- Monitor development of new products to help identify possible problems for mass production.
- Identify quality problems or areas for improvement and recommend solutions.
- Instruct staff in quality control and analytical procedures.
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