Senior Specialist Quality Assurance

Cardinal Health; Aurora (CO); On-site; USD 69,000 - 88,000; Full time

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and procedures in a specialty area, such as recalls and customer complaints, to minimize risks and safeguard supply chain integrity. This role supports the Manager in audits and develops insights for addressing complex issues while mentoring junior staff.

With 2–4 years of relevant experience and a preferred Bachelor's degree, you will contribute to defining SOPs, guiding stakeholders, and ensuring

Qualifications

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks.
• Works on projects of moderate scope and complexity.
• Identifies possible solutions to a variety of technical problems and takes action to resolve.
• Applies judgment within defined parameters.
• Receives general guidance and may receive more detailed instruction on new projects.
• Work reviewed for sound reasoning and accuracy.

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.
• Submits reports for internal review prior to submission to regulatory bodies.
• Executes internal programs to define Quality guidelines and track adherence to these guidelines.
• Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.
• Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.
• Supports the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.
• Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager.
• Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.
• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
• Supports the Manager, Quality Assurance in internal quality audits and inspections.
• Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
• Provides guidance to junior level employees on complex issues, assists with onboarding trainings.

Skills

Quality Assurance

Regulatory understanding

Root cause analysis

Problem solving

Education

Bachelor's degree

Job description

What Quality Assurance contributes to Cardinal Health Quality

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 Senior 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. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area.

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.
• Submits reports for internal review prior to submission to regulatory bodies.
• Executes internal programs to define Quality guidelines and track adherence to these guidelines.
• Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders.
• Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.
• Supports the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.
• Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager.
• Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.
• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
• Supports the Manager, Quality Assurance in internal quality audits and inspections.
• Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
• Provides guidance to junior level employees on complex issues, assists with onboarding trainings.

Qualifications

2-4 years of experience, preferred Bachelor's degree in related field, or equivalent work experience, preferred

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $68,500.00-$88,020.00 Bonus eligible: No

Benefits

• 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: 11/9/26

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

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

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.

View Cardinal Health on YouTube