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Sterility Assurance Scientist
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Maintains procedures and methodologies to cover sterilization programs
Gains and applies knowledge of FDA, ISO and EN sterilization and related microbiology standards and guidelines to all tasks
Supports technical assessments of contract sterilizers and laboratories
Ensures adequacy of contamination control measures at external suppliers
Provides training to procedural changes
Provides input on the resolution of sterility related non-conformances
Supports sterilization validations, cleaning validations, and supporting activities for all product families.
Works with product development to ensure timely and complete sterilization adoptions and validations of all new products.
Trains Product Development personnel in contamination control and sterilization requirements and procedures.
Collaborates with Subject Matter Experts from other departments (i.e. Design Quality Engineering) to ensure a comprehensive approach to bring new and changed product into production.
Assists in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary
Creates and finalizes validation protocols and report ensuring they are lear, concise and compliant to work instructions and standards.
Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance always.
Participate in audits and other compliance program-related activities.
Executes other duties/responsibilities as assigned by manager.
A Bachelor Degree is required, preferably in Microbiology, Biological Sciences or Engineering
1 – 3 years of experience in sterilization/microbiology, medical device, Pharmaceutical and or / food industry is required.
Working knowledge of ISO documents related to sterilization such as ISO 11135 and 11137. Familiar with government regulations and Industry guidelines for sterilization and microbiological control.
Working knowledge of Microsoft Office applications is required.
Ability to effectively work on cross-functional teams, interacting with a diversity of disciplines and locations, including international teams.
Experience writing standard operating procedures, protocols, and test reports is preferred.
Attention to detail. Excellent organizational and time management skills.
Must be able to work under pressure due to reporting deadlines.
Familiarity with basic quality tools and techniques.
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