Senior Specialist Quality Assurance

Regulatory Toolkit; Aurora (CO); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Employee assistance programs

Paid parental leave

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and support the Manager, Quality Assurance in audits and SOP development. This role focuses on recalls, customer complaints, and compliance with regulatory standards to minimize risk and sustain supply chain integrity.

With 2-4 years of experience and a Bachelor's degree, you will mentor junior specialists and contribute to SOP updates while partnering with stakeholders to drive quality improvements.

Qualifications

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

Responsibilities

• Ensures fulfillment of external reporting requirements related to recalls and submits reports for internal review.
• Executes internal programs to define Quality guidelines and track adherence.
• Responds to significant quality issues and conducts root cause analyses with the Manager to inform metrics and trends.
• Supports the Change Control Program by assessing QA implications of changes.
• Updates SOPs in response to product changes and regulatory developments.
• Prepares responses to regulatory queries, audits, and internal audits.
• Supports internal QA audits and inspections and documents findings for stakeholders.
• Guides junior staff and assists with onboarding trainings.

Skills

Quality Assurance

Regulatory compliance

Education

Bachelor's degree

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.

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 of 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: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:11/9/26

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.

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