McKesson
Healthcare
SrAssociateQualityEngineer
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“Sr Associate Quality Engineer at McKesson. Skills: Quality Engineer, Pharmaceutical Quality, Regulatory Environment. Oversight of CAPA program. Review non-conformances”
What You'll Achieve.
Strengthen compliance; Improve process efficiency
Industry & Context.
Identify emerging quality risks; Contribute to continuous improvement
Onsite 5 days a week
What They're Looking For.
Must Have
Degree or equivalent and typically requires 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.
Oversight of CAPA program
Review non-conformances
Execute effectiveness checks
Assist with investigations
Ensure timely CAPA closure
Generate status reports
Analyze data for trends
Maintain company measurements
Repackaging and relabeling projects
Manage special client requests
Perform inspection and release
Review temperature device data
Communicate results to clients
Obtain client approval
Store inspection records
Assist with client activities
Assist with regulatory activities
Assist with validation
How You'll Work.
Team & Collaboration
Partner with Operations; Partner with Account Management; Work with internal departments
Communication Scope
Express ideas clearly; Written communications; Oral communications
Process & Methodology
Project Leader
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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