Quality Assurance Auditor

McKesson Audit Program Specialist

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

Purpose Of Job

Support the audit program of both domestic and international suppliers to ensure compliance with established procedures and requirements. Scope includes initial qualification audits and requalification audits. Perform compliance audits; perform audits of vendor to compliance with FDA current Good Manufacturing Practices.

Key Responsibilities

• Support audit program activities to ensure all audits are performed on time, as required per established audit schedule
• Perform full audits of vendor manufacturing facility; in order to ensure compliance to FDA Regulations and current Good Manufacturing practices
• Travel requirements: 50%-75%, mostly domestic, some international

Additional Responsibilities And Duties

(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description)

Education/Training:

Bachelors degree in Science or related experience

Experience:

• 2+ years of Medical Device auditing, Pharmaceutical auditing, or other Quality Assurance experience in a highly regulated environment
• Demonstrated project management experience
• Experience in performing cGMP audits of Medical Device or Pharmaceutical Manufacturers, or equivalent Medical Device or Pharmaceutical qualification experience.

Knowledge and Skills:

• Good working knowledge and understanding of cGMP21 CFR 820 (FDA regulations) or ISO13485, Quality Standards, Quality Requirements, and Specifications
• Must have good communication skills
• Must be able to effectively communicate in English written and oral
• Must be detail oriented
• Ability to follow instructions and procedures
• Spanish bilingual strongly preferred

PC/Equipment:

• Experience with Microsoft Office Suite

Work Environment/Physical Demands:

Will be working in various manufacturing areas and general office environments.

Career Level:

IC-Professional-P3

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position: $81,000 - $135,000

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.