Quality Assurance Specialist

***Location: Atlanta, GA***

***THIS POSITION IS NOT REMOTE***

***U.S. Citizenship required***

***This job will close when we have received 100 applications which may be sooner than the closing date.***

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.

Basic Qualifications:

Undergraduate and Graduate Education: Major study -- quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position.

or

Specialized Experience (for positions above GS-5): Experience that demonstrated a practical knowledge in monitoring, controlling, or maintaining the quality of products or services in quality assurance, procurement, inspection, production, or related areas. Examples include:

• Reviewing production activities and capabilities in light of contract quality requirements.
• Reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans.
• Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.
• Verifying by test or inspection, using sampling inspection or intensive product inspection techniques, that products comply with requirements prior to acceptance.
• Identifying inadequacies and requesting corrective action.
• Computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods.
• Investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities.
• Reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals.
• Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections.

Minimum Qualifications: You must have one year specialized experience to perform successfully the duties of the position. To be creditable, specialized experience must have been equivalent to at least the GS-11 grade level in the Federal service performing ALL of the following:

• Managing product inspection and compliance for medical countermeasures products such as vaccines, therapeutics, etc.
• Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance.
• Implementing tracking system where all documentation records of product inspection and acceptance are stored.
• Conducting manufacturing facility/site product inspection and acceptance for regulatory compliance.