| Requisition Number: | 12-511 |
| Job Title: | Principal Microbiologist |
| Area of Interest: | Quality |
| Shift: | 1st |
| Position Type: | Full Time - Regular |
| Percentage of Travel Required: | 10% - 25% |
| City: | San Diego |
| State/Province: | California |
| Country: | U.S. |
| Job Summary: | The Volcano Corporation is dedicated to developing breakthrough technologies that save people's lives! At Volcano, you will find a pioneering and innovative spirit with a wide range of opportunities. The Principle Microbiologist will provide leadership for the technical direction, fiscal management and oversight of Sterilization and Microbiology for Volcano Corporation. This position is responsible for directing the strategy and managing Sterilization and Microbiology related projects in a variety of areas. The Principle Microbiologist will function as a project manager for assigned company programs. This position ensures that strategic decisions, as well as key technical decisions for sterilization and microbiology are documented and implemented and that all programs and documentation comply with internal/external standards and regulations. The Principle Microbiologist is the primary contact between Microbiology and Sterilization in Costa Rica and the United States Company Locations.
Responsibilities:
- Set direction and objectives to support the manufacturing of products with microbiological review of operations, review of collected data and support on non-conforming events
- Set direction and manage the sterilization and Microbiological aspects of new product developed at Volcano Corporation; product adoption documents, ethylene oxide sterilization deliverables, and microbiological review objectives are set, monitored, and completed in proper priority
- Set direction and participate in the management of the quality system with development of corrective action deliverables and preventive action details
- Consult on sterilization and quality issues, support problem solving and resolution, and provide counsel to customers for related sterilization and microbiology
- Develop the fiscal control on sterilization and microbiology that will support Volcano Corporation into the future
- Develop direct responsibility role for sterilization and microbiology within manufacturing operations in Costa Rica
Principal Accountabilities:
- Improve and manage microbiological aspects of manufacturing and assure quality and compliance related information and data is accurate, reliable, and supports business objectives
- Develop, implement and maintain documentation systems, procedures and document formats to support the microbiological aspects of manufacturing. Assure compliance with applicable standards, guidelines, policies and regulatory requirements
- Includes product bioburden, controlled environmental monitoring, and endotoxing testing
- Improve and manage microbiological and sterilization aspects of product development processes with data that is accurate, reliable, and support business objectives
- Develop, implement and maintain documentation systems, procedures and document formats to support product development programs. Assure compliance with applicable standards, guidelines, corporate policies and regulatory requirements
- Conduct or assist with sterilization product qualifications, data analysis, and report generation as required, assuring compliance with applicable standards, guidelines, policies and regulations
- Assist with the generation of regulatory documentation and review of product submissions
- Set direction for microbiological and sterilization aspects of manufacturing and sterilization for the facility in Costa Rica
- Work in conjunction with staff in Costa Rica and set direction towards the development, implementation and maintenance of documentation systems, procedures and document formats to support the business demands of Volcano Corporation. Assure compliance with applicable standards, guidelines, corporate policies and regulatory requirements
- Conduct or assist with sterilization product qualifications, equipment qualifications with data analysis, and report generation as required, assuring compliance with applicable standards, guidelines, policies and regulations
- Set Direction and participate in Corporate and Departmental projects to ensure microbiological and sterilization aspects are appropriately represented and minimizes negative regulatory exposure
- Set fiscal direction for the sterilization and microbiology areas of Volcano Corporation
- Manage Microbiology/ Sterilization Technician to include objective setting and daily direction of day-to-day projects
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| Qualifications: | Education/Experience Required:
- Requires knowledge and ability typically associated with a Bachelor's degree in microbiology or related science, with 15+ years of medical device, regulated industries, microbiology or sterilization experience: to include understanding of microbiology for manufacturing, sterilization methodologies, knowledge of FDA requirements, GMP, GLP and ISO
- Evidence of an acquired solid background of technical knowledge and experience, plus successful direction of significant projects, including at a minimum 15 years of functional work direction of quality assurance or operations activities
It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans.
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