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Ralph Feath
Sr. Quality Assurance Auditor
Detail-oriented and thorough Quality Assurance Specialist with 20+ years of experience in cGMP QA/QC/Compliance, with a proven ability and knowledge to manage the day-to-day lifecycle of batch reviews/dispositions, develop and implement process improvements, and consistently deliver high quality support services to internal teams and customers.
Expert in discovering vulnerabilities in processes and implementing quality control strategies resulting in increased productivity , higher sales while meeting and exceeding federal and national compliance requirements.
Proven track record in delivering high-quality inspections and audits by standardizing audit processes and leveraging company and process knowledge to determine areas in need of improvement.
CAREER HIGHLIGHTS Authored and reviewed 10+ SOPs and Safety Data Sheets (SDS) for 300 products ensuring zero liability.
Conducted 30+ internal audits annually resulting in a reduction of findings by 90%, reported all results and assigned necessary corrective actions in response to audit findings.
Led FDA inspection resulting in a no Letter 483 issued.
CORE COMPETENCIES Research & Development Project Management Process Improvement Regulatory Compliance Manufacturing Good Manufacturing Practice (cGMP) Product Lifecycle Management Quality Assurance Batch Review/Disposition Hazard Analysis & Critical Control Points (HACCP) Risk Management & Assessment Change Control Corrective Action Preventive Action (CAPA) Calibration Auditing Laboratory & MicroLab Auditing