KEYLA N. LOPEZ FIGUEROA
Caguas,PR
Summary
Results-driven Quality Assurance and Quality Control professional with over 20 years in the pharmaceutical and biotechnology sectors. Expertise includes quality systems, CAPA management, regulatory compliance, and process improvement. Led quality initiatives, supported FDA inspections, and implemented digital solutions to enhance operational performance across manufacturing and laboratory environments. Bilingual in English and Spanish.
Overview
1
1
Certification
22
22
years of professional experience
Work History
Sr. QA Specialist – Investigations & CAPA
JOHNSON & JOHNSON
Gurabo, Puerto Rico
08.2023 - Current
- Led quality oversight for critical manufacturing events, product quality issues, and compliance-related investigations to maintain product integrity
- Led complex GMP investigations, CAPA programs, deviation management, and quality risk assessments for commercial pharmaceutical operations
- Streamlined investigation cycle times and implemented right-first-time improvements and extension reduction strategies across site quality operations
- Reviewed Nonconformance and CAPA records for the Gurabo Site.
- Implemented digital quality solutions including Smart QA, IM360, AI adoption, Digital Governance, and Next Generation Quality Systems
- Led quality risk assessment workshops and cross-functional governance reviews, enhancing data governance initiatives
- Supported Health Authorities Inspections (FDA), inspection readiness, mock PAI preparation, regulatory response readiness, and enterprise compliance improvement programs
- Partnered with manufacturing, labs, sterility assurance, validation, engineering, and compliance to ensure sustainable GMP compliance
- Spearheaded Credo Action Plans and Women in STEM initiatives, fostering employee development and cross-functional quality initiatives through coaching and technical writing
Sr. Scientist Bioassay / Lead Investigator
JOHNSON & JOHNSON
Manatí, Puerto Rico
01.2015 - 08.2023
- Led investigations ensuring adherence to GMP quality systems and regulatory compliance.
- Led laboratory investigations, CAPAs, change controls, technical assessments, corrections, and remediation activities for commercial biotherapeutic products including Epoetin and Remicade.
- Acted as Laboratory Lead Auditor during Johnson & Johnson mock Pre-Approval Inspections.
- Led remediation and action tracking programs to strengthen laboratory compliance and quality system effectiveness.
- Contributed to FDA information request responses and regulatory assessment activities.
- Coordinated method transfers between global sites and facilitated technical collaboration with international partners.
- Instructed laboratory personnel on new technologies and methodologies.
- Supported internal audits, regulatory inspections, Gemba walks, Kaizen initiatives, and quality culture programs.
- Reviewed and approved technical reports, procedures, work instructions, protocols, and laboratory documentation.
- Organized and facilitated Quality Risk Assessment sessions for the implementation of new investigation processes.
- Led Governance and Criticality Review Board activities.
- Contributed to quality culture, diversity, equity, and inclusion initiatives, and organizational transformation efforts.
QC Senior Associate – Bioassay
AMGEN MANUFACTURING LIMITED
Juncos, Puerto Rico
01.2009 - 01.2015
- Led bioassay testing, including ELISA, gene expression, apoptosis, cell culture, and HPLC analytical activities to ensure accurate and reliable results.
- Led validation and implementation of laboratory automation systems and analytical technologies.
- Facilitated method validation, method transfers, and approval of technical documentation to enhance laboratory operations.
- Contributed to laboratory investigations and quality assessments to uphold compliance with regulatory standards.
- Trained analysts and provided technical leadership to the laboratory organization.
QAL Senior Associate – In-Process Laboratory
AMGEN MANUFACTURING LIMITED
Juncos, Puerto Rico
01.2005 - 01.2009
- Oversight laboratory operations for second shift, ensuring compliance and efficiency.
- Supported manufacturing operations by conducting timely release and in-process testing to maintain quality standards.
- Coordinated laboratory priorities, facilitating compliance during audits and ensuring alignment with regulatory requirements.
Education
Master of Management - Quality Control
University of Turabo
Puerto RicoBachelor of Science - Industrial Chemistry, Natural Sciences
University of Puerto Rico
HumacaoSkills
- Investigation management
- CAPA effectiveness programs
- Deviation management
- Quality assurance operations
- Quality risk management
- Inspection readiness and regulatory audits
- Data integrity and ALCOA principles
- Quality systems implementation
- Parenteral and biopharmaceutical expertise
- Biotherapeutic quality oversight
- Method transfer and validation
- Laboratory operations expertise
- Strategic project management
Certification
- 2012, Certified Quality Auditor (CQA), American Society for Quality (ASQ), 44109
- 2016, Sigma Green Belt Training (ASQ), 15333
- 2016, Six Sigma Black Belt Course (ASQ)
- 2018, Johnson & Johnson Internal Audit Certification
- 2019, Biotechnology Certification, Omni Scientia Corp
- 2024, Human Organizational Performance (HOP) Certification, J&J
- 2024, Train-the-Trainer Certification, J&J
Timeline
Sr. QA Specialist – Investigations & CAPA
JOHNSON & JOHNSON
08.2023 - Current
Sr. Scientist Bioassay / Lead Investigator
JOHNSON & JOHNSON
01.2015 - 08.2023
QC Senior Associate – Bioassay
AMGEN MANUFACTURING LIMITED
01.2009 - 01.2015
QAL Senior Associate – In-Process Laboratory
AMGEN MANUFACTURING LIMITED
01.2005 - 01.2009
Master of Management - Quality Control
University of Turabo
Bachelor of Science - Industrial Chemistry, Natural Sciences
University of Puerto Rico