Quality Assurance Specialist

3 weeks ago


Atlanta, United States Administration For Strategic Preparedness And Response Full time

WHAT YOU'LL BE DOING DAY TO DAY

As a Quality Assurance Specialist, you will use your knowledge of and experience with Administration for Strategic Preparedness and Response (ASPR) to optimize business results and customer experience by:

Performing critical duties required to ensure that the SNS maintains a comprehensive quality control 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 pharmaceuticals products.

Conducting 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), preventive maintenance.

Ensuring that all quality assurance requirements such as SOPs and protocols are in place, controlled, and meet cGMP and other regulatory requirements.

Meeting with program officials and key staff in the ASPR, HHS, and other Federal agencies, along with key contract partner representatives, members of the science- based academic community, and industry to resolve issues associated with the administration and execution of quality control programs.



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