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Sr Associate Quality Engineer

$65.6k - $109.3k

McKesson

McKesson 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, identify emerging quality risks, and contribute 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 the area of responsibility, including reviewing non‑conformances, ensuring documentation, reviewing corrective/preventive actions for completeness, and executing effectiveness checks when required. Assist with Non‑conformance Investigations assigned to Quality Assurance, ensuring timely closure of CAPA records. Generate status reports from applicable QMS applications, analyze data to identify potential trends and areas for improvement, and maintain related company measurements. Repackage and relabel projects in support of client requests as Project Leader (communication with client and Program Manager, pricing proposals, creation of the project protocol, inspection of the project as required by protocol, and filing necessary paperwork). Manage all special client project requests, client complaint memos, and other relevant client memos. Serve as a backup for the Associate Quality Engineer to perform inspection and release processes for incoming and returned product, including downloading and reviewing temperature device data, communicating results to clients, obtaining proper client approval, electronic storage of inspection records, and product retains. Assist with Client and Regulatory activities, quality‑related training, validation of storage areas/systems/equipment when required, and other duties assigned by manager. Shift 11:00 AM – 7:30 PM. This role requires you to be on site 5 days a week. Minimum Job Qualifications Degree or equivalent; 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 with thorough knowledge of word processing, database, and spreadsheet programs (preferably MS Office). Ability to work with internal departments to accomplish objectives and meet established deadlines. Personable, self‑starter, possess a good attitude, enjoyable 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 is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit the Equal Employment Opportunity page. #J-18808-Ljbffr McKesson

Vacancy posted 2 days ago
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