What Sterility Assurance brings to Cardinal Health

　　Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

　　Sterility Assurance performs specialized technical and scientific laboratory testing to ensure the compliance and safety of the company's products. This job family develops and executes precise testing procedures and reports on results in accordance to internal and external requirements.

　　What is expected of you and others at this level

　　Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projectsMay contribute to the development of policies and proceduresWorks on complex projects of large scopeDevelops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectivesCompletes work independently receives general guidance on new projectsWork reviewed for purpose of meeting objectivesMay act as a mentor to less experienced colleaguesQualifications

　　Bachelor’s degree in microbiology, biology, chemistry, physics, engineering preferred or other related scientific field, or related sterilization experience4-8 years professional experience within an FDA regulated industry, preferably medical devices4-8 years working experience in a quality or regulatory role preferred4-8 years working experience in a sterilization or sterility assurance engineering related role preferredMicrobiology lab background experience is preferred but not required.Must be proficient in MS Office applicationsStrong project management and communication skills including scientific technical writing preferredAbility to work a hybrid position (3 days a week in the office / 2 days work from home)Responsibilities

　　Responsible for the supplier management and audits of contract sterilizers and sterility testing support laboratories.Responsible for the deviation investigation and management of contract EO and gamma sterilizers and sterility testing support laboratories, annual requalification, annual reviews, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract sterilizers and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standardsPerform SME technical evaluations of abnormalities in sterilization processing and batch records for product release.Applies problem solving and quality improvement tools and techniques, including, nonconformance, deviation, preventative and corrective actions and how to overcome barriers to quality improvements.Responsible for project management and coordination of activities associated with sterilization process R&D, optimization, validation, product adoptions and special projects (complaint investigation, regulatory compliance, cost savings, etc.), and cross functional teams as assigned.Provides Sterility Assurance SME support to medical device manufacturing sites, sterilization sites, procurement, and cross functional departments and teams.Perform Advanced Technical Writing including authoring of study protocols/final reports and data analysis/ verification.Authoring and maintenance of procedure, policy, and form updates within quality system. Evaluation of procedures for compliance and alignment to industry standards.Demonstrates advanced understanding of quality philosophies, principles, systems, methods, tools, and standards.Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.Trains, mentors, and develops less experienced colleagues within Sterility AssuranceAnticipated salary range: $78,500 - $117,705

　　Bonus eligible: No

　　Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

　　Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 03/16/2024 *if interested in opportunity, please submit application as soon as possible.

　　Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

　　Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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　　We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. We are Essential to care.

　　Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities

　　We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

　　With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

　　On Thursday, Jan. 7, 2021, we celebrated the day our founder, Bob Walter, had the vision to start a business that became known as Cardinal Health.

　　One of the most important ways we celebrated was by giving back to the communities where we live and work. 2021 was a "Year of Service” for all Cardinal Health employees around the world.

　　View Cardinal Health on YouTube (http://youtube.com/user/CardinalHealth)

　　Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.