Kyle Rifenbery

Manager, Quality Assurance @博士伦

Tampa, FL, US

Lead and mentor a high-performing team of 35 QA professionals across three core functions; Batch Record Review, Laboratory Data Review, and Floor QA•Oversee end-to-end review and release of batch records and product, ensuring timely, accurate, and compliant product disposition•Manage the review and release of QC Chemistry and Microbiology testing results, ensuring data integrity, GMP compliance, and timely approval•Manage Floor QA activities, providing real-time quality oversight through line inspections, in-process checks, and AQL sampling to ensure operations meet regulatory and quality standards•Partner with cross-functional teams (Manufacturing, QC, Supply Chain, etc.) to resolve quality issues, implement corrective actions, and prevent recurrence•Oversee investigations and resolution of laboratory deviations and out-of-specification (OOS)/ out-of-tolerance (OOT) events, ensuring timely documentation and regulatory compliance•Monitor key quality metrics (e.g, documentation/performance errors, turn-around-times, etc.) to track team performance and drive accountability•Serve as a site host for regulatory inspections, ensuring seamless coordination of documentation, responses, and team interactions to ensure smooth, compliant audit execution•Act as a site representative for global B&L forums (aseptic, regulatory, etc.), driving compliance and harmonization by sharing key performance indicators, regulatory updates/findings, and best practices across the global network

Whitworth University

Bachelor of Science (B.S.), Biology, General

Ephrata High School

High School Diploma