SHAWNNIE A. HUERTAS MELÉNDEZ
Summary
Laboratory Analyst with over 4 years of experience supporting Quality Systems, regulatory compliance, investigations, CAPA effectiveness, document control, and continuous improvement initiatives within a GMP-regulated manufacturing environment. Experienced in audit readiness activities, SOP development and revision, quality training delivery, root cause analysis, and cross-functional. Recognized for contributions to analytical method validation and implementation projects. Strong analytical, technical, and communication skills with a demonstrated commitment to quality, compliance, and continuous improvement.
Overview
5
5
years of professional experience
Work History
Laboratory Analyst
BACARDI CORPORATION
Cataño
11.2021 - Current
- Support Quality Management System (QMS) activities through document control, SOP development, revision, and compliance initiatives within a GMP-regulated manufacturing environment.
- Participate in laboratory investigations by gathering facts, documenting findings, performing root cause analysis using tools such as 5 Whys and Fishbone Analysis, and supporting corrective and preventive action (CAPA) implementation.
- Conducted CAPA effectiveness assessments to verify implementation and sustainability of corrective actions addressing quality and compliance risks, ensuring ongoing regulatory adherence.
- Support audit readiness activities through documentation review, record verification, logbook assessments, and personnel preparation for internal and external audits.
- Collaborated on global compliance investigation for training completion requirements, partnering with Human Resources and cross-functional stakeholders to enhance training oversight and regulatory compliance.
- Delivered training programs to more than 150 employees on GMP requirements, document control, ISO 9001 Context of the Organization, SOP revisions, equipment operation, and regulatory compliance topics.
- Trained and qualified six laboratory analysts on laboratory procedures, equipment operation, data integrity, and compliance requirements.
- Served as Acting SQS Coordinator, supporting document management activities, employee training, and ISO 9001 compliance initiatives.
- Reviewed, revised, migrated, and maintained more than 100 controlled documents and SOPs in support of Quality Management System requirements.
- Supported large-scale document migration and periodic review initiatives for manufacturing and laboratory-controlled documentation.
- Led laboratory documentation optimization initiative, through consolidation and streamlining processes, maintaining compliance with Quality Management System requirements.
- Validation and implementation projects through protocol development, SOP authoring, report generation, and Performance Qualification (PQ) execution.
- Analyze laboratory and process data to identify trends, support informed decision-making, and contribute to continuous improvement initiatives.
Education
Bachelor of Science - Chemistry
University of Puerto Rico
Mayagüez Campus01-2021
Skills
- Quality Management Systems (QMS)
- GMP Compliance
- Document Control
- SOP management
- Quality Investigations
- CAPA verification
- Root cause analysis
- Audit Readiness Support
- Risk Assessment
- Data Analysis & Trending
- Analytical instrumentation: HPLC, Gas Chromatography (GC), Mass Spec
- Project Coordination
- Cross-functional teamwork
- Training & Development
Systems And Software
- SAP
- LIMS
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Microsoft Teams
Languages
- Spanish, Native
- English, Fluent
Research
Undergraduate Research – Analytical Chemistry, University of Puerto Rico – Mayagüez Campus, Participated in analytical chemistry research focused on laboratory experimentation, data analysis, technical documentation, and scientific problem-solving.
Timeline
Laboratory Analyst
BACARDI CORPORATION
11.2021 - Current
Bachelor of Science - Chemistry
University of Puerto Rico