Sterility Assurance Principal Scientist

Cardinal Health

7d•Remote

About The Position

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. This is fully remote position within the United States. Job Summary Under the general direction of the Director, Sterility Assurance, this role provides technical expertise and manages special projects in the areas of sterilization, sterility assurance, microbiology and analytical chemistry laboratory testing, controlled manufacturing and product evaluations to ensure the sterility and regulatory compliance of products in Cardinal Health’s Medical segment. As a subject matter expert in microbiology, sterilization, cleanroom technology and relevant regulatory requirements, this role works on cross-functional teams to develop actionable insights for ensuring quality, cost savings, operational improvements and innovation especially focused on Ethylene Oxide and Radiation Sterilization processes.

Requirements

Bachelor’s degree in microbiology, biology, chemistry, biochemistry, physics, or engineering preferred, or other related scientific field or equivalent work experience preferred.
4+ years professional experience within an FDA regulated industry, medical devices preferred.
4+ years working experience in a quality or regulatory role preferred.
4+ years working experience in a sterilization or sterility assurance engineering related role preferred.
Proficiency in MS Office applications and with strong project management and communication skills including scientific technical writing, preferred.
ISO 11135 (Ethylene Oxide) and ISO 11137 and 13004 (Radiation) experience preferred.

Nice To Haves

Microbiology lab or clinical background experience is preferred.

Responsibilities

Demonstrates advanced understanding of quality philosophies, principles, systems, methods, tools, and standards.
Develops, and implements quality programs, including tracking, analyzing, reporting and problem solving.
Responsible for project management, coordination of activities, and SME technical support associated with controlled manufacturing, sterilization process R&D, development, optimization, and validation, as assigned.
Perform sterilization process development, chamber qualification/validation, equivalency, parametric release statistical evaluations/process maintenance and implementation activities across internal and external contract sterilizers according to ANSI/AAMI/ISO requirements.
Perform Advanced Technical Writing including authoring of study protocols/final reports and data analysis/ verification.
Responsible for project management, SME support, and coordination of activities associated with special projects (complaint investigation, regulatory compliance, cost savings, manufacturing operations, transformation/changes, etc.), and cross functional teams as assigned.
Responsible for the supplier management of contract sterilizers and support laboratories.
Responsible for advanced sterilization related nonconformance, deviation, and CAPA investigations.
Perform SME technical evaluations of abnormalities in sterilization processing and batch records for product release and lead special studies in support of product release.
Authoring and maintenance of procedure, policy, and form updates within quality system.
Evaluation of procedures for compliance and alignment to industry standards, performance of gap assessments, and driving of mitigation solutions and best practices.
Support and management of Sterility Assurance programs such as Environmental Monitoring, Bioburden Monitoring, Product Adoption, and Sterilization Metrics, as assigned.
Provides Sterility Assurance SME support to medical device manufacturing sites, sterilization sites, laboratories, procurement, cross functional departments and project teams.
Support and perform supplier audits including contract sterilizers, manufacturers, and microbiological and analytical laboratories.
Support regulatory compliance audits as SME.
Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
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.
Applies problem solving and quality improvement tools and techniques, including preventive and corrective actions and how to overcome barriers to quality improvements.
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.