QualityAssuranceCoordinator

Job Summary: The QA Coordinator – Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:30pm Responsibilities/Essential Duties: Investigations and CAPA Management Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience Bachelor’s degree in Life Sciences, Engineering, or related technical field required. Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. Demonstrated expertise in managing deviations and CAPAs, Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7–Q10, and relevant USP chapters. Proficiency i