Quality 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.

The Quality Specialist supports the day-to-day quality work for US Pharmaceutical Distribution. This includes reviewing temperature excursions, completing product quality investigations, supporting corrective and preventive actions (CAPA), and helping with recalls and quality system activities. The role works within established procedures and uses good judgment to complete assigned work, make recommendations, and raise higher-risk or unfamiliar issues when needed.

• →Reviews and documents routine to moderately complex temperature excursions, product quality issues, investigations, CAPAs, and critical events. Follows established procedures and raises significant risks or unusual issues promptly.
• →Creates and maintains accurate records in the electronic quality management system. Supports approved process and system changes and helps make sure new requirements are put into practice.
• →Collects and reviews investigation data, metrics, and trends. Identifies possible issues and recommends follow-up actions for review.
• →Works with Operations, Compliance, distribution centers, Technology, and outside partners to complete assigned activities on time. Keeps the right people informed and follows up on open items.
• →Applies relevant FDA requirements, 21 CFR, the Drug Supply Chain Security Act, United States Pharmacopeia standards, Good Distribution Practice, current Good Manufacturing Practice, and internal procedures to assigned work. Helps prepare for audits and inspections.
• →Writes clear and complete investigation records, reports, and communications.
• →Makes sure required information is entered in the appropriate system on time.
• →Participates in training, team discussions, and improvement activities.
• →Shares lessons learned and helps promote consistent quality practices.

Degree or equivalent and typically requires 4+ years of relevant experience.

Bachelor's degree in science, engineering, pharmacy, quality, or a related field, or equivalent experience.

• 4+ years of experience in pharmaceutical quality, investigations, CAPA, recalls, regulated distribution, cold-chain operations, quality systems, or a similar regulated environment.
• Experience applying quality procedures to routine and moderately complex issues and knowing when additional guidance is needed.
• Ability to organize work, manage priorities, meet deadlines, and complete assignments with general supervision.
• Good attention to detail and a consistent approach to accurate, timely, and compliant documentation.
• Ability to review information, recognize possible risks, and make practical recommendations within established guidelines.
• Clear written and verbal communication skills and the ability to work effectively with colleagues in different functions.
• Working knowledge of applicable FDA regulations, 21 CFR, the Drug Supply Chain Security Act, Good Distribution Practice, current Good Manufacturing Practice, investigations, root cause analysis, CAPA, quality risk management, and data integrity.
• Experience with electronic quality management systems, Microsoft Office applications, quality data, and technical documentation.
• Ability to work primarily from a remote location and collaborate regularly with distribution center personnel, cross-functional teams, and corporate partners.
• Ability to occasionally work in a distribution center, operational, or warehouse environment to support investigations, audits, and quality activities.
• Ability to travel domestically, including occasional overnight travel, up to 10%.
• Ability to work for extended periods at a computer and review detailed electronic records, data, and quality documentation.

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. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. 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.

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McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca. Resumes or CVs submitted to this email box will not be accepted.