Lisa Ward

Over 15+ years of product, process and analytical experience in an FDA regulated industry with focus in supporting quality assurance, GMP compliance, regulatory requirements and production controls, to deliver high value and customer service. Direct supervision/management of QC and QA teams. Created a collaborative experience by aligning objectives of safety, quality and compliance, providing value in work assignments, performance reviews, training, motivating, and mentoring/coaching to achieve timelines. Cross-functional team member for development projects in coordinating project expectations, priorities, deliverables, assuring a standard of excellence, and resolving issues to help meet short-term and long-term requirements. Assuring incoming materials are from approved suppliers, meet specification prior to being released for production. Reviewed and ensured that the finished product met rigorous specifications, labeling, quantity and delivery requirements. Performed and authored quality deviation investigations, CAPAs, root cause analysis, customer complaints, and FMEAs. Assessed, implemented, and monitored corrective and preventative actions to improve testing and process requirements. Representative for quality internal audits and as required onsite and virtual external customer audits and regulatory audits.