Sr. Sterility Assurance Scientist

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Sr. Sterility Assurance Scientist Apply locations US-MA-Mansfield-190-Facility time type Full time posted on Posted 8 Days Ago job requisition
-4148

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

• Serves as a Subject Matter Expert for Sterilization across the company.
• Maintains and revises procedures and methodologies to cover sterilization programs across sites.
• Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines, for example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements.
• Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans
• Subject matter expert with regard to technical assessments of contract sterilizers and laboratories.
• Monitors and ensures adequacy of contamination control measures at external suppliers.
• Provides training to procedural changes.
• Provides guidance and input on the resolution of sterility related non-conformances
• Supports sterilization validations, cleaning validations, and supporting activities for all product families by setting company policy and direction for these activities.
• Works with product development to ensure timely and complete sterilization adoptions and validations of all new products including the introduction of new novel sterilization processes.
• 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 sites as an expert consultant in sterile release, bioburden and dose audit, and environmental monitoring programs as necessary
• Creates and finalizes validation protocols and report ensuring they are clear, 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.

Integra Life Sciences 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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