Quality Control Specialist/Microbiologist
ISO 22716:2009, Follow Good Manufacturing Practices (GMP) Interfaces with all R&D departments, Technical Services, Manufacturing and NY Products Department.Determines stability of formulations and ensures commercial feasibility.Follows projects from prototype development through manufacturing.Contributes in establishing manufacturing procedures.Assures that all testing to guarantee a marketable final product is on schedule.Establishes standards and submits batch cards to lab management for review.Certificate of Analysis Submission.Study growth, structure, development, and general characteristics of bacteria and other micro-organisms.Make cultures of significant bacteria or other micro-organisms in prescribed or standard inhibitory media; controlling factors, such as, aeration, temperature, and nutrition.Take part in bacteriological, and mycological examinations on a variety of samples, specimens, and products against microbiology specifications for product release.Prepare culture media and other reagents.Monitor environmental characteristics of the sitePerform and review environmental monitoring (EM), water and other utility testing to ensure the ongoing suitability and status of clean rooms and equipment.