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Cardinal Health
Alabama, United States
14 days ago

Description

Accountabilities

  • Develop risk-based audit schedules based on company procedures and supplier performance. 
  • Independently conduct audits of suppliers and internal processes as identified by Quality Assurance management.
  • Establish and maintain audit and supplier standard operating procedures.
  • Document and report quality and compliance issues to QA management as necessary.
  • Must be able to develop an audit report, verify, document, and communicate audit results, and evaluate the effectiveness of corrective action.
  • Prioritizes and ensures work is delivered in an efficient way.
  • Creates risk assessments for suppliers where required
  • Collaborates cross functionally to ascertain audit findings identified.
  • Performs other job duties as assigned.

A Covid-19 vaccination or a legitimate accommodation is required in order to be employed in this position. Covid-19 vaccination includes:

  • 2 doses of the Moderna or Pfizer vaccine
  • 1 dose of the Johnson & Johnson vaccine
  • Please note vaccines may be required for the position subject to federal, state and/or customer requirements.

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.



Requirements

Experience and Qualifications

  • Bachelor’s in science or related field, or equivalent work experience preferred
  • ASQ CQA preferred; other certifications may be considered
  • Lead Auditor experience required, including
    • API and parenteral products
    • Sterilization methods
    • Organizing, planning, and executing a Master Audit List
    • Execution of audits as a lead auditor
    • Development and submission of audit reports
    • Monitoring CAPA’s and closure of audit reports
    • Summarizing and trending audit observations
    • Presenting to Management results and trends of audits
  • Experience with technology such as SharePoint, Zoom, Microsoft, Tableau, Vault as well as other platforms to facilitate remote audits where required.
  • Experience with technology, such as Excel, Tableau, Vault, to trend, analyze and monitor audit reports and schedule.
  • Preferable to have 5+ years of experience in an Audit role supporting US FDA and International pharmaceutical products.
  • Possess an understanding of cGMP/compliance requirements for pharmaceutical and medical device products.
  • Up to 50% travel required.

What is expected of you and others at this level

  • Ensures compliance with regulations, domestic and international, and controls by examining and analyzing records, reports, operating practices, and documentation.
  • Prepares for audits by researching materials, standards, policies, and procedures to formulate a plan of action.
  • A leader of communication to escalate Quality concerns to management when identified through audits
  • Applies comprehensive knowledge and a thorough understanding of concepts, principles, regulatory requirements, and technical capabilities to perform varied tasks and projects.
  • Contributes to the development of policies and procedures.
  • Works on complex projects of large scope.
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.
  • Completes work independently to meet overall business objectives and personal goals; receives general guidance on new projects.
  • May act as a mentor to less experienced colleagues.

Job Information

  • Job ID: 64811663
  • Location:
    Alabama, United States
    Arizona, United States
    Arkansas, United States
    California, United States
    Connecticut, United States
    Delaware, United States
    Florida, United States
    Georgia, United States
    Idaho, United States
    Illinois, United States
    Indiana, United States
    Iowa, United States
    Kansas, United States
    Kentucky, United States
    Louisiana, United States
    Maine, United States
    Maryland, United States
    Massachusetts, United States
    Michigan, United States
    Minnesota, United States
    Mississippi, United States
    Missouri, United States
    Montana, United States
    Nebraska, United States
    Nevada, United States
    New Hampshire, United States
    New Jersey, United States
    New Mexico, United States
    New York, United States
    North Carolina, United States
    North Dakota, United States
    Ohio, United States
    Oklahoma, United States
    Oregon, United States
    Pennsylvania, United States
    Rhode Island, United States
    South Carolina, United States
    South Dakota, United States
    Tennessee, United States
    Texas, United States
    Utah, United States
    Vermont, United States
    Virginia, United States
    Washington, United States
    West Virginia, United States
    Wisconsin, United States
    Wyoming, United States
    Dublin, Ohio, United States
  • Position Title: Principal QA Supplier Auditor
  • Company Name For Job: Cardinal Health
  • Job Function: QA/QC/Compliance
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 3-5 Years
  • Required Travel: 25-50%

Please refer to the company's website or job descriptions to learn more about them.

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