Job SummaryWe 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
Responsibilities- Quality Documentation & Compliance: 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
- Microbiology Expertise: Apply and, ideally, possess experience or knowledge in product microbiology method validation (e.g., Bioburden, BET, sterility methods) and microbiology identification
- Environmental Monitoring Trend Analysis: Review periodic Environmental Monitoring (EM) trend analysis for PET facilities, identifying and escalating negative trends to management
- Investigation Leadership: 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
- Cross-Functional Collaboration: Partner closely with Manufacturing, Quality Assurance, Engineering, Validation, Training, and Supply Chain teams to support timely investigation closure, process improvements, and manufacturing readiness
- Data Integrity & GDP: Ensure all documentation adheres to strict Good Documentation Practices (GDP) and ALCOA+ principles, demonstrating a strong understanding of data integrity
- Audit & Inspection Readiness: Support audit and inspection readiness activities by providing documentation support and responding to quality system inquiries
- Operational Excellence: Participate in initiatives focused on process simplification, documentation standardization, and right-first-time execution
- Technical Support: Provide support to all PET manufacturing for investigations, fact-finding activities, troubleshooting, and Microbiology assessments
- System Utilization: Utilize manufacturing and quality systems as required, including eBR, Veeva, SAP, and Microsoft Office applications, to manage records and track timelines
- Training Support: 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
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
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
Anticipated salary range: $80,900 - $103,950
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
- 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
Application window anticipated to close: 09/21/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
