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, please click here.
Our Base Pay Range for this position$79,100 - $131,900
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: careers.mckesson.com.
