Quality Assurance Specialist
Summary
Ensures pharmaceutical product quality by inspecting SNS facilities for cGMP compliance, reviewing documentation, and tracking deviations to maintain regulatory standards.
This position is located in the Department of Health and Human Services, Administration for Strategic Preparedness and Response, headquartered in Washington, District of Columbia. This announcement will close at 11:59 PM, on the day that 100 applications have been received or the closing date of the announcement, whichever comes first.
As a(n) Quality Assurance Specialist, you will: Perform duties required to ensure that the SNS maintains a comprehensive quality control program and that cGMP standards and other regulatory guidelines are adhered to by SNS staff and contract partners during the receipt, storage, handling, transport, and shipping preparation of pharmaceutical products. Conduct regular inspections of SNS facilities to document cGMP compliance and identify deficiencies; reviews facility data and documentation, including, but not limited to, equipment validations, document control system, temperature monitoring, product cold chain, deviations, corrective and preventive actions (CAPAs), and preventive maintenance. Review and recommend modification as necessary of the criteria for testing and validating temperature monitoring equipment, computerized systems, cold-storage units, and other equipment required under cGMP for the maintenance of pharmaceutical products to ensure data is valid and reliable and cannot be manipulated. Participate in ongoing analyses and tracking/trending of events in support of the cGMP Quality Systems.