The Sr. QA Material Supplier Specialist assures that raw materials used in manufacturing are of the appropriate quality for the production of drug products.
This position will manage individuals who accomplish project objectives by planning and evaluating project activities. They will support Quality Assurance project initiatives, Regulatory and Partner inquires, Specifications, as well as audit activities for a broad range of topics relating to Materials and Supplier Quality, Quality Management and Supplier Performance.
As a Sr. QA Material Supplier Specialist, a typical day might include the following :
Ensures accurate and timely qualification of materials
Performs continuous improvement of the program using a variety of methodologies (QRM, Lean, etc.)
Supports the resolution of deviations (NOEs and DNFs) related to raw materials.
Gathers, evaluates and provides information / documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
Prepare and complete action plans; implementing efficiency, quality, and customer-service standards.
Resolve problems, identify trends and determine system improvements and implement change within the guidelines of GMP
Maintain project timelines associated with quality assurance initiatives to support the evolving business
In order to be considered for this position, you must hold a BS / BA in business, life sciences or a related field and the minimum years of experience required for each level :
Sr. Specialist : 5+ years
Principal Specialist : 8+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
REGNQA
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