Microbiology Laboratory Sr. Supervisor
hace 1 día
COMPANY OVERVIEW
BVI is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium Intraocular Lenses).
Purpose:
As a Microbiology Laboratory Leader, you will become a key member of our Juarez quality team at BVI. You will support manufacturing operations through the oversight of the site microbiology laboratory activities and QMS, including controlled area environmental monitoring, performance of bioburden, sterility, and endotoxin testing, and sterilization release. You will drive operational efficiency, continuous improvement, and ensure the highest quality standards are maintained.
Key Responsibilities:
Oversee and maintain the quality management system of the microbiology laboratory in accordance with ISO 17025.
Responsible for the oversight, management, and training of the microbiology laboratory personnel.
Responsible for the performance of microbiological tests of the product within the plant, including bioburden, sterility, endotoxin, plate counts, and particle counts, and ensuring the maintenance and cleanliness of the microbiology laboratory.
Develop and perform validations of microbiology lab equipment, cleanrooms, controlled areas, and utilities, including performing testing for validation and ongoing monitoring, and reviewing the data to identify trends.
Responsible for monitoring, auditing, and reviewing external testing laboratories, as well as associated procedures.
Responsible for the compliance of external standards as applicable to the controlled areas and the microbiology laboratory.
Responsible for sterilization release and collaborating with the site sterilization engineer on the performance of the industrial sterilization processes.
Review and resolve problems identified through environmental monitoring and microbiology laboratory testing, including the documentation of out of specification reports and corrective and preventive actions (CAPA), and communication to operations staff regarding the risks and actions for resolution.
Review and assess changes impacting environmental and endotoxin monitoring.
Perform continuous improvement activities to maintain compliance to current standards, reduce variation in the process, and eliminate activities that do not add value using problem solving, six sigma, and lean principles.
Qualification:
Bachelor of Science in Microbiology, Biology, Biotechnology, Pharmaceutical Biology, or other biological scientific discipline (Master's Degree is preferred) plus a minimum of five years' work experience as an industrial microbiologist, or an equivalent combination of education and experience.
Bilingual Spanish- English
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