Specialist, Quality Assurance

Quality Assurance Specialist

Quality Assurance contributes to Cardinal Health by developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. 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.

The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities.

Responsibilities include :

• Leading the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers
• Loading and extracting product systematic data on substances within Cardinal Health Master Data systems
• Reviewing and evaluating received questionnaire forms for completeness and applicability
• Coordinating with Supplier, Sourcing, Quality, Regulatory, and Manufacturing teams to obtain information necessary to complete assigned tasks
• Identifying and quantifying risk, communicating results effectively to management
• Supporting management of QRA policies governing product quality data
• Identifying quality and regulatory related issues within current processes, investigating and providing recommendations
• Interacting with cross-functional business partners to assist in the execution of the current Medical Distribution Quality Plan
• Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health
• Demonstrating working knowledge of applicable laws and regulatory concepts utilized to manage risk
• Supporting development of programs, policies, and procedures using knowledge of regulatory requirements and technologies
• Proactively developing and maintaining a broad knowledge of the technical disciplines in own functional area; applying broad knowledge of trends and best practices in a manner that ensures exceptional performance and results
• Using deep subject matter / functional expertise; influence and process skills to help internal / external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications
• Encouraging informed risk-taking and acting as a catalyst for innovation at Cardinal Health; generating practical, sustainable, and creative options to solve problems and create business opportunities, while maximizing existing resources
• Championing and leading change initiatives; identifying the best approach for implementing strategic processes in light of cultural and diversity implications

Qualifications : Bachelors degree preferred, 1-3 years experience preferred, knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP, and California Proposition 65 preferred, Distribution Operations processes (Medical and Pharmaceutical) preferred. Excellent verbal, written, computer, SAP, and interpersonal skills required. Excellent influencing skills. Must be able to multitask and work with competing priorities.

What is expected of you and others at this level includes : understanding complex functional situations by paying attention to the details of the tasks at hand and breaking them down into smaller pieces, proactively developing and maintaining broad knowledge of the technical disciplines in own functional area(s); applying broad knowledge of trends and best practices in a manner that ensures exceptional performance and results, using deep subject matter / functional expertise, influence and process skills to help internal / external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications, encouraging informed risk-taking and acting as a catalyst for innovation at Cardinal Health; generating practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources, championing and leading change initiatives; identifying the best approach for implementing strategic processes in light of cultural and diversity implications.

Anticipated hourly range : $26.90 per hour - $36.90 per hour. Bonus eligible : No. Benefits include medical, dental and vision coverage, paid time off plan, health savings account, 401k savings plan, access to wages before pay day, flexible spending accounts, short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

Application window anticipated to close : 12 / 07 / 2025. 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 candidates 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.