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.

Job Summary

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

Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers

Load and extract product systematic data on substances within Cardinal Health Master Data systems

Review and evaluate received questionnaire forms for completeness and applicability

Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks

Identify and quantify risk, communicate results effectively to management

Support management of QRA policies governing product quality data

Identify quality and regulatory related issues within current processes, investigate and provide recommendations

Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in 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

Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk

Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies

Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces

Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results

Uses 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

Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources

Champions and leads change initiatives; identifies 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

Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces

Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results

Uses 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

Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources

Champions and leads change initiatives; identifies 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 : 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 : 12 / 07 / 2025