William Berger

Executive Director, Quality Control Compliance @KVK Tech, Inc.

Newtown, PA, US

As Corporate Quality (Site Level QC Compliance) reporting to CEO:o Oversight and QC release of Raw Materials, Finished Product, Stability.o Support of FDA Compliance Remediation for site Quality Systems through enhancement of Deviations, CAPAs, Complaints, and Change Controls.o Lead auditor at critical CDMOs.o Directed site improvement of environmental monitoring program and sanitization programs at oral solid/liquid dose plant in response to FDA observations.o Improving root cause analysis in laboratory investigation and reduction in human errors leading to greater than 80% reduction investigations.o Two direct reports and headcount around 40 individual contributors.Work cross functionally to ensure compliance across all sites.