Job Description
Responsibilities
Coordinate biological testing activities, including bioburden, sterility, biocompatibility, and other testing programs performed by external third-party laboratories. This includes supporting both routine quality activities and research and development (R&D) projects.Coordinate and monitor quarterly, semi-annual, and other scheduled laboratory audits to ensure they are completed accurately and within established timelines.Prepare, review, and maintain testing protocols, study plans, and final laboratory reports in accordance with applicable quality and regulatory requirements.Analyze laboratory data, identify trends, and support investigations into test results and performance metrics.Coordinate purchase requisitions and purchase orders related to external laboratory testing services.Collaborate with Engineering, Production, Quality, and other cross-functional teams to coordinate the collection, preparation, and s...
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