Quality Assurance Supervisor

📋 Description

• Manage and execute product and system investigations including deviations, OOS/OOT results
• Ensure timely initiation, impact assessment, and documentation of investigations in accordance with
• Apply structured root cause analysis methodologies such as 5-Whys, Ishikawa (fishbone), and Six
• Facilitate cross-functional investigation meetings and maintain high-quality documentation aligned
• Drive the creation, approval, and execution of Corrective and Preventive Actions (CAPAs)
• Ensure all CAPAs are specific, measurable, timely, and effective in addressing the root cause

🎯 Requirements

• Bachelor's degree in Life Sciences, Engineering, or related technical field required
• Minimum 5 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical
• Demonstrated expertise in managing deviations, CAPAs, and change control systems
• Experience with FDA inspections and supporting regulatory audits is strongly preferred
• Technical Skills:
• In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-QIO, and relevant USP chapters

🎁 Benefits

• Competitive Compensation including base salary and annual performance bonus
• Flexible PTO, holidays, and parental leave
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance