Job Description Summary
The Quality Sterilization Analyst is responsible for supporting activities to maintain the sterilization assurance program. This includes sterilization cycle reviews, investigation of out-of-specification results, performing laboratory tests and protocol execution.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Sterilization Analyst will support the quality sterilization team in support of functions critical to the safety of medical devices. The role is responsible for understanding performing sterile batch release process, supporting the validation of new and existing sterilization processes, and analytical lab processes such as: GC-FID, Environmental monitoring, Biological Indicator, Product Sterility testing and inoculating test samples.
Responsibilities include but are not limited to:
Support and perform investigations as it pertains to sterilization.
Understand routine laboratory procedures to include Biological Indicator (BI) testing and placement, EO residuals testing, environmental monitoring testing and trend analysis, microbial identification, product sterility testing, B/F testing, SDA (Sterilization Dose Audits) and bioburden testing.
Provide support during on site audits of Sterilization and also support the audits that occur at contract sterilizers.
Support Continuous Improvement activities around Sterilization: cycle time optimization, testing time optimization, safety awareness, new Sterilization site Qualification.
Implements metrics to support the control of the Sterilization process.
Perform routine analysis of EO/ECH residual testing of terminally sterilized medical using gas chromatography (GC-FID).
Participate as a member of special project teams, as assigned, including support of sterilization, QC microbiology, R&D and plant objectives.
Ability to provide knowledgeable representation during laboratory audits.
Authors and revises SOPs utilizing an SAP document management system.
Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous Waste regulations.
Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Other duties as required to support the needs of the business.
Qualifications:
Two (2) years relevant experience or a combination of relevant experience and education (i.e. semester hour in a scientific discipline).
Must be able to lift and/or move up to 45 pounds.
Experience with LabWare and SAP (preferred).
Experience with microbiology and sterilization related standards (e.g. ISO/ANSI/AAMI 11135, ISO-11737, ISO 10993-7) (preferred).
Strong computer literacy (Excel, Word, etc.).
Ability to define, organize, and manage individual tasks.
Effective verbal and written communication skills.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA UT - SandyAdditional Locations
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