Principal Specialist, Quality Assurance - Microbiology

About the role

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. We are seeking a highly motivated and detail-oriented Microbiology Principal Specialist to join our Quality team supporting PET facilities and Microbiology laboratory.

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

Qualifications

• 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

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Pay

Anticipated salary range: $80,900 - $103,950

Schedule

Application window anticipated to close: 09/21/2026