Cardinal Health Quality and Regulatory Auditor in CA, United States

Quality & Regulatory Audit is responsible for assessing the processes and practices at pharmacy and manufacturing sites throughout the U.S. to minimize risk and ensure compliance with regulatory agencies such as NRC, State Radiological Health Agencies, DOT, BOP, and OSHA while focusing on patient and employee safety.

This position can be located anywhere in the U.S.. West or Midwest strongly preferred. 90% of travel.

Accountabilities

  • Conducts on-site inspections requiring travel (air and car) 90% of the time and possessing the ability to work on your own initiative as well as part of a team.
  • Utilizes pharmaceutical education, training, and experience to ensure compliance in areas related to State Boards of Pharmacy, USP, OSHA, and FDA compliance.
  • Utilizes regulatory training and experience to ensure compliance in areas related to the NRC and State Radiological Health Agencies.
  • Ensures procedures, policies, and regulations are correctly followed and maintained to the highest degree of compliance through examination of records, reports, operating practices, training, and documentation.
  • Prepares audit reports and trend analysis through data obtained during audit process.
  • Prepares reports for management concerning the scope of the audit, regulatory issues and concerns, and projected outlook for future regulatory compliance.
  • Maintains auditing program by updating audit forms and documents and recommending new policies and procedures to the Pharmacy Practice Committee and Radiation Safety Committee.
  • Calls on past management and professional skills to influence the behavior of field employees without authority.
  • Observes the flow and interactions at the nuclear pharmacy, PET locations and manufacturing sites to analyze and suggest operational improvements.
  • Acts as the face of NPS Q&R during audits as well as a liaison between the field and Quality and Regulatory.
  • Brings insight to Quality and Regulatory as to conditions of and usefulness of programs to the field.

Qualifications

  • Pharmacist/Health Physicist, preferred
  • 8+ years experience in related field preferred
  • Must have excellent communication and interpersonal skills
  • Microsoft Office (Word, Excel, PowerPoint) skills
  • 90% of travel

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.