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Form of workWhat 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 projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues
Qualifications
Bachelor’s degree in microbiology, biology, chemistry, physics, engineering preferred or other related scientific field, or related sterilization experience
4-8 years professional experience within an FDA regulated industry, preferably medical devices preferred
4-8 years working experience in a quality or regulatory role preferred
4-8 years working experience in a sterilization or Sterility Assurance engineering related role preferred
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, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across contract sterilizers and quarterly gamma dose audit testing according to ANSI/AAMI/ISO standards
Perform 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 Assurance
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.
