Quality Engineer, Plasma

McKesson•Shepherdsville, KY

11d•$79,100 - $131,900•Onsite

About The Position

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.

Requirements

Degree or equivalent experience.
Typically has 4+ years of relevant experience
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.

Nice To Haves

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.

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.