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.
Manages all special client project requests, client complaint memos, and other relevant client memos.
Assists as needed with Client and Regulatory activities, Quality-related training, validation of storage areas/systems/equipment where required, and other duties and responsibilities as assigned by manager.
Shift:
11:00AM - 7:30pm THIS ROLE REQUIRES YOU TO BE ON SITE 5 DAYS A WEEK.
Minimum Job Qualifications:
Degree or equivalent and typically requires 2+ years of relevant experience.
Critical Skills:
3-5 years in a pharmaceutical quality/regulatory environment, preferred
Quality Management System and/or Document control management experience, preferred.
Knowledge of pharmaceutical regulations, including FDA requirements, preferred.
Preferred Skills:
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.
Our Base Pay Range for this position
$65,600 - $109,300
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
Benefits
Health insuranceEquity / stock optionsPerformance bonus
Additional Information
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.
Mckesson · KY, Shepherdsville