Quality Assurance Coordinator

📋 Description

• Leads or supports investigations for deviations, OOS/OOT, nonconformances, and complaints.
• Ensures timely, complete, compliant documentation per 21 CFR 211.192 and ICH Q9/Q10.
• Performs structured root cause analysis (5-Why, Fishbone, FMEA).
• Develops and manages CAPAs linked to verified root causes and timelines.
• Analyzes trends in investigations and CAPA data; reports metrics to Quality leadership.
• Ensures ALCOA+ data integrity; records are inspection-ready.

🎯 Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 1–4 years QA experience in cGMP pharma/OTC/medical devices.
• Experience managing deviations and CAPAs; FDA inspections preferred.
• Root cause tools: 5-Why, Fishbone, FMEA; Six Sigma.
• eQMS experience: MasterControl, Veeva, ETQ Reliance; ALCOA+ data.
• Strong analytical, cross-functional collaboration and documentation.

🎁 Benefits

• Competitive pay with base salary and annual bonus.
• Paid time off, holidays, and floating holidays.
• Healthcare, HSA match, 401(k) match, wellness programs.