McKesson

healthcare

SrAssociateQualityEngineer

$66–109k Shepherdsville, Kentucky, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“Sr Associate Quality Engineer at McKesson. Skills: Quality Management System, CAPA program oversight, Client project management. advanced quality oversight across daily operations. incident management”

What You'll Achieve.

drive risk-based decision making; strengthen compliance; improve process efficiency; ensure timely closure of CAPA records; identify potential trends and areas for improvement

Industry & Context.

healthcare
Problems you'll solve

identifies emerging quality risks; contributes to continuous improvement initiatives

Eligibility Requirements

ON SITE 5 DAYS A WEEK

What They're Looking For.

Must Have

2+ years of relevant experience

Nice to Have

3-5 years in a pharmaceutical quality/regulatory environment, Quality Management System and/or Document control management experience, Knowledge of pharmaceutical regulations, including FDA requirements, Ability to express ideas clearly both in written and oral communications, Ability to enter data accurately, Ability to handle multiple tasks well, Detail-oriented individual with thorough knowledge of word processing, database, and spreadsheet programs (preferably MS Office), Must possess the ability to work with internal departments to accomplish objectives and meet established deadlines, Must be personable, self-starter, possess a good attitude, and enjoy external and internal contact on the phone and in person with supervisors, co-workers, customers, and potential clients

What You'll Do.

advanced quality oversight across daily operations

client-facing quality activities

oversight of the Corrective Action/Preventive Action (“CAPA”) program

review all non-conformances

review all corrective/preventive actions

execute effectiveness checks

assist with Non-conformance Investigations

ensuring timely closure of CAPA records

generating status reports from applicable QMS applications

analyzing data to identify potential trends and areas for improvement

maintaining related company measurements

repackaging and relabeling projects in support of client requests

communication with client and Program Manager regarding project details

pricing proposals for project

creation of the project protocol

inspection of the project as required by project protocol

filing any necessary paperwork with client

manages all special client project requests

client complaint memos

other relevant client memos

serves as a back-up for the Associate Quality Engineer to perform the inspection and release process for incoming and returned product

downloading and review of temperature device data

communicating results to clients

obtaining proper client approval

electronic storage of inspection records

assists as needed with Client and Regulatory activities

Quality-related training

validation of storage areas/systems/equipment where required

other duties and responsibilities as assigned by manager

How You'll Work.

Team & Collaboration

partners with Operations, Account Management, and internal/external customers; work with internal departments to accomplish objectives

Communication Scope

Ability to express ideas clearly both in written and oral communications; communication with client and Program Manager regarding project details; communicating results to clients

Process & Methodology

Project Leader for repackaging and relabeling projects, manages all special client project requests

Full 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. The Senior Associate Quality Engineer is responsible for advanced quality oversight across daily operations, incident management, investigations, and client-facing quality activities. This position partners with Operations, Account Management, and internal/external customers to act as a quality liaison to drive risk-based decision making, identifies emerging quality risks, and contributes to continuous improvement initiatives to strengthen compliance and process efficiency. **Key Responsibilities** * Responsible for the oversight of the Corrective Action/Preventive Action (“CAPA”) program for their area of responsibility including but not limited to review all non-conformances to ensure they are documented, review all corrective/preventive actions for completeness, and execute effectiveness checks when required. * Assist with Non-conformance Investigations assigned to Quality Assurance, as needed. Responsible for ensuring timely closure of CAPA records. * Responsible for generating status reports from applicable QMS applications, analyzing data to identify potential trends and areas for improvement, and maintaining related company measurements. * Responsible for repackaging and relabeling projects in support of client requests, as Project Leader. Including, but not limited to, communication with client and Program Manager regarding project details, pricing proposal

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