Quality Engineer, Plasma

McKesson Corporation; Shepherdsville (KY); On-site; USD 79,000 - 132,000; Full time

Job summary

McKesson seeks a Quality Systems professional in Kentucky to develop, implement, and maintain quality processes, ensuring regulatory compliance and product integrity across operations.

You will lead CAPA, incident management, audits, and temperature monitoring, partnering with cross-functional teams to improve efficiency and service quality while supporting client requirements.

Qualifications

• Degree or equivalent experience; typically 4+ years of relevant experience.
• Prior CAPA, investigations, audits, and quality systems in a regulated environment preferred.
• Experience in pharmaceutical, biologics, medical device, or healthcare logistics preferred.

Responsibilities

• Monitor and manage daily quality operational workflows
• Develop, implement, revise, and maintain quality standards, procedures, and work instructions to support regulatory and client requirements
• Identify and implement process improvements to reduce costs and improve service quality
• Address and resolve operational quality issues, escalating complex problems to management as needed
• Ensure oversight of IMS records, including review of non-conformances and CAPA for completeness
• Conduct End of Route document review and publish results, including training documentation
• Manage client unit pulls to ensure SOP compliance
• Inspect and release shipments, verify temperature device placement and paperwork
• Program temperature devices for outbound shipments
• Conduct facility inspection records to ensure SOP compliance
• Provide temperature certification documentation to clients
• Support calibration management, alarm testing, and qualification activities
• Review weekly temperature graphs from Facility Temperature Monitoring System
• Support internal and client audits and regulatory inspections
• Assist with special projects and other duties as assigned by manager

Skills

Detail-oriented

MS Office

Problem-solving

Communication

Education

Degree or equivalent

Job description

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.

Position Summary (Purpose of job):

This position is responsible for developing, implementing, maintaining, and continuously improving quality systems, processes, and compliance programs to ensure adherence to client, regulatory, and company requirements. This role provides site-level quality oversight for operational processes, inspections, incident management, corrective and preventive actions (CAPA), temperature monitoring programs, and quality metrics. The position serves as a subject matter expert for quality systems and compliance, partnering cross-functionally with internal and external partners to ensure product integrity, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

• Monitor and manage daily quality operational workflows
• Develop, implement, revise, and maintain quality standards, procedures, and work instructions to support regulatory and client requirements.
• Identify and implement process improvements to enhance efficiency, reduce costs, and improve service quality.
• Address and resolve operational quality issues, escalating complex problems to management as needed.
• Ensure oversight of Incident Management System (IMS) Record, including but not limited to review all non-conformances to ensure they are documented, review all corrective/preventative actions for completeness, execute effectiveness checks when required, trending, and assist as needed with non-conformance investigations assigned to Quality Assurance.
• Conducts End of Route document review and publishes results, including ensuring Plasma Transportation Drivers training documentation is complete.
• Manages client unit pulls to ensure compliance to SOPs.
• Conducts inspection and release process of shipments, including but not limited to verification of temperature device placement and actively recording, verifying shipping paperwork for accuracy and adherence to client requirements.
• Programs temperature devices for outbound shipments, as per client requirements.
• Conducts facility inspection records to ensure compliance to SOPs.
• Provides temperature certification documentation to clients on a timely basis, as requested.
• Support calibration management, alarm testing, and qualification activities to ensure compliance to SOPs.
• Review weekly temperature graphs from Facility Temperature Monitoring System.
• Support internal audits, client audits, and regulatory inspections.
• Assists with special projects and other duties and responsibilities as assigned by manager.

Minimum Job Qualifications (Knowledge, Skills, & Abilities):

Education/Training/Experience

• Degree or equivalent experience. Typically has 4+ years of relevant experience
• Preferred experience supporting CAPA, investigations, audits, and quality systems in a regulated environment preferred.
• Preferred experience in pharmaceutical, biologics, medical device, healthcare logistics, or related industry experience preferred.

Specialized Knowledge/Skills

• Ability to express ideas clearly both in written and oral communications.
• Detail-oriented individual with ability to enter data accurately.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Must possess the ability to work with internal departments to accomplish objectives and meet established deadlines.
• Ability to work effectively in a fast-paced, dynamic environment.
• Excellent problem-solving, decision-making, and organizational skills.

Working Conditions:

Environment (Office, warehouse, etc.)

• Working conditions include office conditions and warehouse freezer conditions at approximately -30 Celsius

Physical Requirements (Lifting, standing, etc.)

• Ability to stand for extended periods
• Ability to lift up to 50 pounds

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, pleaseclick here.

Our Base Pay Range for this position

$79,100 - $131,900

McKesson is an Equal Opportunity Employer

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) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!