D Louis
Tamarac,FL
Summary
Strategic executive with 10 years of leadership in Quality Assurance and Operations specializing in local, state, and federal regulations such as FDA (CFRs) and CLIA. Extensive expertise in managing cross- functional teams to successfully meet performance targets and elevate operational performance through innovative quality strategies, compliance management, and budget management boosting profitability by 39% . Dedicated to safeguarding plasma center ensuring purity and efficacy of plasma products and clients’ safety.
Overview
9
9
years of professional experience
Work History
Center Director
Proesis Bio
Miramar, FL
01.2022 - Current
- Spearhead the overhaul of plasma operational processes, resulting in a 39% increase in profitability through optimizing efficiency, fostering team development, budget management, and strategically allocating resources.
- Successfully manage and mentor cross-functional teams, fostering a culture of accountability and continuous improvement, resulting in a 50% increase in donor retention and satisfaction. Strengthen relationships with key stakeholders, such as regulatory bodies and community partners, elevating the center's reputation and expanding its industry's influence.
- Ensured compliance with applicable laws, regulations, and policies regarding plasma product management, maintaining optimal health and safety standards.
Quality Assurance Manager
Proesis Bio
Miramar, FL
01.2020 - 01.2022
- Directed the implementation of a rigorous Quality Management System (QMS), ensuring the center exceeded all regulatory standards, with a reduction in compliance issues. Led the initiative to streamline SOPs and quality protocols, driving a 30% increase in operational efficiency and significantly reducing error rates.
- Directed quality systems development, including root cause analysis and corrective actions, which resulted in a 15% reduction in production nonconformances.
- Conducted internal audits of processes, products, and systems to ensure compliance with quality standards.
- Maintained and updated QMS to ensure continuous improvement and effectiveness.
Quality Manager
Immunotek Bio Centers
West Palm Beach, FL
01.2017 - 12.2019
- Led adherence to all HSE standards, OSHA guidelines, and CGMP practices, resulting in a zero-incident record for two consecutive years.
- Directed the full implementation of Standard Operating Procedures (SOPs), ensuring consistent quality across all operations and reducing operational risks.
- Managed thorough investigations into incidents affecting donors, employees, and visitors, leading to improved safety measures and a more secure environment.
- Conducted training sessions for employees on quality assurance processes, techniques and tools.
- Monitored product performance against customer specifications and standards, ensuring that all products met the required standards.
- Ensured effective implementation of corrective actions to resolve any identified issues or discrepancies in a timely manner.
Quality Manager
Octapharma Plasma Center
Gretna, LA
07.2015 - 12.2019
- Conducted thorough reviews and investigations into manufacturing processes, equipment, and methods, ensuring alignment with quality objectives and reducing deviations by 25%.
- Trend data to implement effective quality strategies, addressing areas of concern, and enhancing overall operational effectiveness.
- Maintained strict compliance with federal, state, and local regulations, earning the facility an A rating during audits.
Education
Bachelor of Arts - Business Administration And Management
Florida Agricultural And Mechanical University
Tallahassee, FL05-2015
Skills
- Quality Assurance, Compliance & Regulations CFRs (FDA)
- Corrective and Preventative Action (CAPA)
- Risk Analysis and Deviations Quality Management System (QMS)
- Operational Management
- Budget Planning & Management Continuous Improvement
- Quality Auditing Stakeholder Engagement
- Team Leadership & Development
Timeline
Center Director
Proesis Bio
01.2022 - Current
Quality Assurance Manager
Proesis Bio
01.2020 - 01.2022
Quality Manager
Immunotek Bio Centers
01.2017 - 12.2019
Quality Manager
Octapharma Plasma Center
07.2015 - 12.2019
Bachelor of Arts - Business Administration And Management
Florida Agricultural And Mechanical University
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