Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including process validation reports, manufacturing technical documents, stability reports and process flow diagrams.
The Quality Assurance Engineer is responsible for developing manual and automated tests to support business initiatives. This individual will be a pivotal member of an Agile Scrum team working closely with developers, product owners, and UX to drive a successful testing strategy. This individual should be passionate about quality.
In this role, the candidate will display knowledge of infrastructure security certification and accreditation policies and procedures. Leverage the ability to work on annual DIACAP and RMF packages, respond to audit requests, and provide documentation and artifacts supporting CCRI, FISCAM and other audits.
The Performance Assurance Data Analyst includes the collection and analysis of data for the purpose of drawing inferences; identifying correlations; identifying cause and effect relationships; and making predictions.
Lead /participate in the design, implementation, effective use and maintenance of electronic tools (e.g. Design Controls, CAPA, Risk Management, Production, Supplier Quality Management, and Documentation Management solutions) to support diagnostics quality systems.