Principal Specialist, Quality Assurance - Microbiology

Cardinal Health•Lewis Center, OH

2d•$80,900 - $103,950

About The Position

What Quality 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. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary We are seeking a highly motivated and detail-oriented Microbiology Principal Specialist to join our Quality team supporting PET facilities and Microbiology laboratory. This role is crucial for maintaining compliance with cGMP regulations and internal quality standards by reviewing and managing critical quality documentation. The ideal candidate will be a technical resource, leading investigations, driving corrective actions, and contributing to operational excellence initiatives. The Principal Specialist supports audit readiness and collaborates cross-functionally to enhance operational excellence and ensure data integrity, ultimately safeguarding product safety and efficacy. Additionally, this individual will provide secondary support for identification, media, and other microbiological method testing within the microbiology department. The Principal Specialist plays a pivotal role in Cardinal Health's PET facilities' Quality Assurance, ensuring rigorous compliance with cGMP regulations and internal quality standards. This is achieved through meticulous management of quality documentation, application of microbiology expertise for product safety, and proactive identification and resolution of issues via investigation leadership and root cause analysis. These core Quality Assurance activities are critical for maintaining product quality, mitigating risks, and upholding the company's commitment to delivering safe and effective products. Furthermore, this role significantly contributes to the overall Quality Assurance system by fostering cross-functional collaboration, ensuring data integrity, and supporting audit readiness. Within the Quality Assurance framework, this specialist is a vital technical resource, providing crucial support for manufacturing investigations and driving process improvements. Their work is fundamental to fortifying Cardinal Health's robust quality system, optimizing manufacturing efficiency, and upholding its reputation for reliability and patient safety

Requirements

Bachelor's degree in microbiology, Biology, or a related scientific field, preferred
4-8 years of experience, preferred
Proven experience in a cGMP regulated environment, preferably within the pharmaceutical or medical device industry
Comprehensive knowledge and thorough understanding of cGMP concepts, principles, and technical capabilities
Demonstrated ability to lead investigations and perform root cause analysis using recognized methodologies (e.g., 5-Whys, Fishbone diagrams)
Basic knowledge of Data Integrity & GDP and ALCOA+ principles
Excellent technical writing and communication skills
Ability to work effectively in a cross-functional team environment
Proficiency in using quality management systems (e.g., Veeva) and enterprise resource planning (ERP) systems (e.g., SAP) is a plus
Strong organizational skills and attention to detail

Responsibilities

Author, review, and manage deviations, CAPAs, technical reports, SOP updates, and other microbiology-related documentation to ensure strict compliance with cGMP regulations, principles, and internal quality standards for Cardinal Health PET facilities
Apply and, ideally, possess experience or knowledge in product microbiology method validation (e.g., Bioburden, BET, sterility methods) and microbiology identification
Review periodic Environmental Monitoring (EM) trend analysis for PET facilities, identifying and escalating negative trends to management
Independently lead out-of-specification (OOS) and trend investigations, performing thorough root cause analysis, driving effective corrective and preventive actions, and ensuring clear, concise, and inspection-ready technical writing
Partner closely with Manufacturing, Quality Assurance, Engineering, Validation, Training, and Supply Chain teams to support timely investigation closure, process improvements, and manufacturing readiness
Ensure all documentation adheres to strict Good Documentation Practices (GDP) and ALCOA+ principles, demonstrating a strong understanding of data integrity
Support audit and inspection readiness activities by providing documentation support and responding to quality system inquiries
Participate in initiatives focused on process simplification, documentation standardization, and right-first-time execution
Provide support to all PET manufacturing for investigations, fact-finding activities, troubleshooting, and Microbiology assessments
Utilize manufacturing and quality systems as required, including eBR, Veeva, SAP, and Microsoft Office applications, to manage records and track timelines
Support training initiatives related to investigation findings, deviation writing, documentation practices, and GMP compliance expectations
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