Quality Specialist

Job Summary

A company is looking for a Specialist Manufacturing.

Key Responsibilities

• Address and close quality records (Deviations, CAPAs, Supplier Event Notifications, and Change Control) ensuring compliance with regulatory requirements
• Monitor and investigate deviations, implementing corrective and preventive actions while partnering cross-functionally
• Build and present quality records summaries for Senior Management review and provide timely updates on processes and statuses

Required Qualifications

• 3-5 years of hands-on experience managing deviations, change controls, and CAPAs
• Experience with quality records in biotech or medical device industries
• Basic project management skills
• Bachelor's degree preferred; associate degree holders with significant experience (10+ years) may be considered
• Strong grasp of root cause analysis and investigation review