Posted in Information Technology 3 months ago.
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Location: Palm Beach Gardens, Florida
Responsible for management of those quality assurance programs and functions related to all microbiological testing, environmental monitoring of cleanrooms, and sterilization processing. Provides guidance and leadership in the development, evaluation, and validation of sterilization processes. Manages those QA activities required to support, evaluate, document, and audit the microbiological control and sterilization of products. Prepares and coordinates the testing and sterilization documentation required for FDA submissions, for foreign country product registrations, and for compliance with current GMP’s/European Medical Device Directives/ISO Standards.
Determine and define quality assurance requirements for microbiology, biocompatibility, citoxicity testing, environmental and clean rooms and/or to ensure compliance to industry standards, government specifications or other applicable source documents. Formulate, write and maintain procedures, specifications and standards for the quality control of Zimmer Biomet products (specifically microbiology testing, biocompatibility testing, environmental controls and clean rooms). Lead the establishment of the environmental and clean room controls as required for the development and manufacturing of Zimmer Biomet products Lead the microbiology, biocompatibility and citoxicity testing as required for the Zimmer Biomet products. Design, develop, and manage research and validation projects pertaining to microbiological control and sterilization processes. Leads Corrective and Preventive actions as applicable to the areas of responsibilities. Provide technical guidance to Development Engineering, Research, Manufacturing, Purchasing, and Regulatory Affairs Departments on issues related to microbiological control and product sterilization. Develop and implement training programs for all Environmental Lab technicians, Microbiology Lab technicians, and manufacturing cleanroom personnel. Ok Conduct GMP/ISO audits of contract sterilization vendors and testing laboratories.
This position exercises extensive independent decision making in the application of scientific principles based on interpretation of medical device regulations, industrial sterilization guidelines, and international standards. Actions taken by this position can effect a broad range of company operations including laboratory testing, process validation, product development, manufacturing, regulatory submissions, and international product licensing. Must have prior experience with validation of industrial sterilization processes. Must have a thorough knowledge of Medical Device GMPs, industrial sterilization guidelines, and ISO standards. Must possess excellent written and oral communication skills. Experience in GMP auditing and preparation of procedures is desirable.
Bachelor of Science in Microbiology, Biology or related field, plus 6-8 years experience in microbiology or sterile medical devices with at least 3 years supervisory experience, or equivalent combination of education and experience. Experience in microbiology testing, biocompatibility and citoxicity testing is required. Experience establishing and monitoring environmental and clean room requirements, maintenance and controls is required. Quality Engineering Certification (ASQ) a plus Experience in GMP auditing and preparation of procedures is desirable.
Up to 10%