
Posted 17 days ago
Senior Associate Quality Engineer
McKessonSr Associate Quality Engineer
Requirements
Degree or equivalent, 2+ years relevant experience, 3-5 years pharmaceutical quality/regulatory experience preferred, Quality Management System experience preferred, Knowledge of FDA requirements preferred, MS Office proficiency
Skills
Quality Management SystemCAPAFDA Regulations
About the role
Responsibilities
- Oversee the Corrective Action/Preventive Action (CAPA) program, including reviewing non-conformances and executing effectiveness checks
- Assist with non-conformance investigations and ensure timely closure of CAPA records
- Generate and analyze status reports from QMS applications to identify trends and areas for improvement
- Act as Project Leader for repackaging and relabeling projects, managing client communication and project protocols
- Manage special client project requests, complaint memos, and other relevant documentation
- Serve as backup for the Associate Quality Engineer regarding the inspection and release process for incoming and returned products
- Support client and regulatory activities, quality-related training, and validation of storage systems or equipment
Requirements
- Degree or equivalent
- 2+ years of relevant professional experience
- Proficiency in MS Office (word processing, databases, and spreadsheets)
- Ability to work on-site 5 days a week (Shift: 11:00 AM – 7:30 PM)
Preferred Qualifications
- 3-5 years of experience in a pharmaceutical quality or regulatory environment
- Experience with Quality Management Systems (QMS) or document control management
- Knowledge of pharmaceutical regulations and FDA requirements
- Strong written and oral communication skills with high attention to detail
About the Company
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. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas to shape the future of health.
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Get started — it's freeSenior Associate Quality Engineer
McKesson · Shepherdsville
