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SUMMARY
Under direct supervision of the Director, Quality Reliability Microbiology, this individual will have a dotted line reporting structure to the local site quality leader. Responsibilities associated with this Sr. Microbiologist, include working with sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. This position reports into Global Laboratories, Microbiology, and Sterility Assurance department and working with the Anasco Integra manufacturing site.
Qualified candidates must possess relevant experience as a Microbiologist in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below.
• Controlled environment monitoring
• Water system monitoring
• Bacterial endotoxin test method validation and monitoring
• Bioburden test method validation and monitoring
• Reusable Medical Devices
• Radiation sterilization validation and dose audit management
• Ethylene oxide sterilization validation and requalification
• Reprocessible device cleaning and sterilization validation
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
• Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.
• Design experimental plans to address specific microbiological quality issues as needed.
• Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.
• Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including, but not limited to, FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, and USP.
• Interpret microbiological data to identify trends and issues that require investigation.
• Contribute to risk management activities including PFMEA generation.
• Scheduling coordination, material allocation and alignment of personnel to successfully complete project assignments.
• Create site procedures for microbiological testing and sampling in alignment with global procedures, validations, and in compliance with application regulations.
• Mentors non-senior level microbiology staff.
• Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources.
• Experience with controlled environment monitoring, water system monitoring, compressed air monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management, and reprocessible device cleaning and sterilization validation is strongly preferred.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.
• Change control, non-conformance and CAPA support as a microbiology and sterility assurance subject matter expert.
• Support the department manager with providing direction to the team, coordinating work flow, and providing guidance in the resolution of problems or areas of concern.
• Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Minimum required education and experience:
• Bachelor’s degree or equivalent with 6+ years of experience, Master degree with 3+ years of experience, Doctoral degree with 2+ years of experience. Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
• Demonstrates excellent organizational and communication skills.
• Results oriented with a strong focus on quality principles.
• Excellent technical writing skills with an understanding of good documentation practice.
• Experience conducting microbial test method validations and managing projects independently.
• Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
• Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 176647, and USP.
• Ability to track milestones and manage projects.
• Working knowledge of applicable regulations and their interpretation within industry.
• Ability to travel 5-10%.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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