Principal Specialist, Quality Assurance - Microbiology

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. 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 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 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. #J-18808-Ljbffr