Senior QA Specialist – Recalls & Audits

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexibile spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Senior Specialist in Quality Assurance to execute quality programs and procedures in recalls and customer complaints, minimizing risks and preserving supply chain integrity.

You will mentor junior specialists, support audits, and help develop SOPs under the Manager, Quality Assurance.

This on-site role requires adapting to scheduling demands and delivers a comprehensive benefits package and competitive compensation.

Qualifications

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

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.

Education

Bachelor's degree in related field

Job description

Cardinal Health is seeking a Senior Specialist in Quality Assurance to execute quality programs and procedures in recalls and customer complaints, minimizing risks and preserving supply chain integrity.

You will mentor junior specialists, support audits, and help develop SOPs under the Manager, Quality Assurance.

This on-site role requires adapting to scheduling demands and delivers a comprehensive benefits package and competitive compensation.