What Sterility Assurance contributes 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 working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Qualifications
Bachelor’s degree in microbiology, biology, or engineering preferred, or other related scientific field or equivalent experience in related field
2-4 years professional experience within an FDA regulated industry, preferably medical devices
2-4 years working experience in a quality or regulatory role preferred
2-4 years working experience in a sterilization or sterility assurance quality/engineering related role
Microbiology lab background experience is preferred but not required.
Must be proficient in MS Office applications
Strong project management and communication skills including scientific technical writing preferred
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, and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standards
Perform technical evaluations of abnormalities in sterilization processing and batch records for product release.
Perform sterilization process development, chamber qualification/validation, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract sterilizers.
Technical Writing including authoring of study protocols/final reports and data analysis/ verification.
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.
Authoring and maintenance of procedure, policy, and form updates within quality system.
Support with coordination of the daily activities of operations, or business support staff
Decisions have a direct impact on work unit operations and customers
Frequently interacts with subordinates, customers, and peer groups at various management levels.
Interactions normally involve information exchange and basic problem resolution
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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