Chief Operations Officer
CurrentIn my current role as COO, I oversee the complete employee lifecycle, including recruitment, training, performance evaluation, and personnel management while conducting workers' compensation audits and administer the 401k plan and ensure compliance with annual form 5500 reporting requirements. Some key achievements in this role include: • Led the company through a comprehensive remediation plan to address observations highlighted by an FDA audit, resulting in the resolution of a warning letter.• Achieved a Voluntary Action Indicated status in the most recent FDA inspection, demonstrating compliance with minimum regulatory requirements.• Implemented an efficient inventory management process to ensure adequate stock levels for timely product manufacturing based on customer demands.• Established standardized processes and procedures across multiple departments, including Quality Assurance, Quality Control, Production, Purchasing, and Stability Management.• Served as the lead point of contact during FDA inspections.• Conducted equipment, process, and product qualifications to ensure compliance with regulatory standards.• Coordinated with vendors to establish Electronic Data Interchange (EDI) software and streamlined accounting software integration.• Established new protocols and procedures for order receiving, processing, and shipping to enhance operational efficiency.• Effectively negotiated pricing agreements with vendors, commercial insurance policies, service providers, and large-scale projects.• Conducted annual negotiations for business and medical insurance renewals, optimizing coverage and cost-effectiveness.• Enhanced the employee evaluation process by incorporating self-evaluation, identifying growth opportunities for employees.• Achieved cost savings by renegotiating terms and restructuring contracts, resulting in reduced fixed expenses.• Managed employee unemployment claims, particularly during dispute resolution and hearing processes.
