Sr Sterility Assurance Scientist
Sr Sterility Assurance Scientist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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 nonconformances
- 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 programrelated activities.
- Executes other duties/responsibilities as assigned by manager.
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.
This site is governed solely by applicable U.S. laws and governmental regulations. If youd like more information on your rights under the law please see the following notices:
EEO Is the Law EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation please email us at or call us at.
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Required Experience:
Senior IC
Employment Type
Full-Time
