Principal Specialist, Quality Assurance - Change Management

Job description

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 The Principal Specialist, Quality Assurance – Change Management is responsible for leading and administering Quality Assurance activities related to change control, quality systems, and SAP master data management within the Nuclear & Precision Health Solutions (NPHS) PET manufacturing environment. This role applies cGMP and quality systems expertise to support complex projects, facility and product expansions, and cross-functional initiatives while ensuring compliance with regulatory requirements, quality standards, and internal procedures. The Principal Specialist serves as a key partner to Quality, Manufacturing, Purchasing, Engineering, and other stakeholders, providing guidance on change management processes, maintaining quality-related systems and data integrity, supporting electronic quality applications, and driving timely issue escalation and resolution. This position operates independently, develops innovative solutions to complex quality challenges, and may mentor colleagues to support continuous improvement and organizational objectives. Responsibilities Quality Assurance administration and management of NPHS Change Controls Quality Assurance support/administration of various PET projects, including facility and product expansion Administrator for maintaining SAP master data of facility equipment for proper asset management and maintenance setup Administrator for maintaining SAP master data of materials, including primary and secondary inspection plans, and ensuring consistent quality control parameters, inspection characteristics, and sampling procedures in alignment with QMS standards Partner with Purchasing team to create new SAP materials, ensuring comprehensive documentation of all process steps required for accurate and compliant material setup within SAP Security Administration for NPS PET Manufacturing Services with Isotrac QA and Chromeleon programs Managing content and security in NPS PET Quality SharePoint site Ability to network and work closely with cross functional teams throughout NPHS to achieve positive outcomes Escalates issues to management in a timely manner Qualifications Bachelor's degree in related field, or equivalent work experience, preferred 4-8 years of experience, in the Pharmaceutical Industry or other regulated manufacturing industry preferred Heavy knowledge and experience Microsoft Office programs Knowledge and experience in programs such as SAP, ISOtrac, Chromeleon, preferred Strong attention to detail Ability to manage timelines and priorities Ability to work independently with minimum guidance Ability to multi-task Travel expectations of 10% depending on business needs and project demands 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. 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. To read and review this privacy notice click here