Extensive scientific and technical writing experience including Standard Operating Procedures, Deviations, Investigations, Change Control, CAPA, Out-of-Specification Reports, Audit Reports, Manufacturing Records and Validation Protocols (IQ/OQ/PQ)•Point of contact for clients on compliance issues during all phases of product development, manufacturing, testing, packaging/labeling and distribution•Supported regulatory submissions by writing, reviewing and editing content•Supported continuous quality improvement initiatives and audit readiness •Hosted and facilitated client and agency audits (FDA, DEA, QP)•Served as lead auditor for external suppliers and laboratories to assess GMP compliance •Internal auditing of aseptic and oral dosage manufacturing suites, GMP storage areas, and QC laboratories •Served as lead QA supervisor for all stages of the aseptic manufacturing process •Developed and delivered up-to-date GMP training methods for all new and current employees •Experience with project management, cleanroom microbiology, controlled substance procedures, product complaints, root cause analysis, product disposition, GMP, GCP, GLP, ISO, CFR 210 & 211, EU, ICH guidelines