Open To Work
Shamayla Hernández
San Juan
Summary
Results-driven Quality Control Laboratory Chemist with over a decade of experience in the pharmaceutical industry, specializing in project and change management. Proven expertise in regulatory compliance and the development of standard operating procedures (SOPs), consistently achieving process optimization and fostering effective team leadership. Skilled in conducting thorough scientific reviews and implementing preventive actions to uphold stringent quality standards. Committed to driving continuous improvement and ensuring excellence in laboratory practices.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Quality Control Laboratory Senior Chemist (Hybrid Remote)
Lilly del Caribe Inc.
12.2021 - 01.2026
- Conducted method improvement efforts in the laboratory
- Lead daily activities for testing validation for new and commercial products.
- Conducted comprehensive regulatory reviews of laboratory practices, ensuring compliance with FDA regulations and improving operational efficiency for annual product review.
- Review analytical data in Darwin Laboratory Information Management Systems (LIMS) to support sample management processes, data accuracy and quality control.
- Evaluate practices in the laboratory to assure appropriate execution, improve analysis and / or reduce variability.
- Provide workshops / Darwin LIMS training to QCL personnel.
- Perform statistical analysis software using Tableau, Darwin LIMS, Smart Lab and Microsoft Excel.
- Lead comprehensive investigations and root cause analyses, utilizing CAPA tools to enhance laboratory operational efficiency and ensure compliance with domestic and international test regulations.
- Identify and lead the implementation of continuous improvement efforts and support strategic initiatives.
- Review SDS sheets to support global chemical regulations for raw materials and chemicals.
- ACHIEVEMENTS: Reduce impact in final release results in-process method variability reduction. Provide analytical school integrating the areas of operation and laboratories.
Quality Control Laboratory Chemist (Hybrid Remote)
Lilly del Caribe Inc.
06.2012 - 11.2021
- Supervise analysts/ coordinate activities in support of daily testing activities from sample receive until sample discarding.
- Verify analytical data
- Provide support / troubleshoot daily activities for lot release.
- Lead analytical investigations
- Played a crucial role in audit preparations and quality documentation utilizing Trackwise expertise to maintain rigorous compliance and support continuous improvement efforts. Review and create technical documents and protocols. Generate or verify the laboratory documentation and paperwork including (without limitation), laboratory data, procedures, protocols.
- Perform the holistic assessment of lots prior release from laboratory.
- Ensured FDA compliance and adherence to cGMP by developing and maintaining Standard Operating Procedures (SOPs) and conducting regular audits, resulting improvement in regulatory adherence.
- Provide data for USP forum communications related to monograph proposals.
- ACHIEVEMENTS: -Team up to reduce testing backlog at the laboratory. - Validated three cleaning methods
Research Analyst
Eli Lilly and Company
08.2017 - 09.2017
- Collaborated on a cross-disciplinary team to develop and implement a community health initiative to improve the knowledge of gestational diabetes before and after its diagnosis. The initiative focuses to provide patients knowledge about the disease and guideline to maintain an optimal levels of sugar though education. The result was to a 20% improvement in local engagement.
Quality Assurance Specialist
Genetech Biomedical, Inc.
09.2008 - 06.2012
- Directed comprehensive internal audits of facility records, Standard Operating Procedures (SOPs), and training materials, thereby enhancing compliance and operational standards through the identification and rectification of procedural gaps.
- Improved customer service standards by swiftly addressing complaints and inquiries, which led to enhanced calibration service satisfaction rates. Initiated modifications to SOPs and policies to align with evolving audit requirements and industry best practices.
- Lead external Environmental Health and Safety audits, building collaborative relationships with regulatory inspectors and ensuring adherence to stringent environmental regulations. Analyzed audit data to strategize improvements in safety protocols and operational efficiency.
Education
Master of Public Health - Environmental Health
University of Puerto Rico
San Juan, PR01-2016
Bachelor of Natural Science - Chemistry
University of Puerto Rico
Rio Piedras, Puerto Rico01-2007
Skills
- Easily Adaptable
- Leadership
- Conflict Resolution
- Public Speaking
- Time Management
- Strong Organization Skills
- Strong Written and Verbal Communication
- Self-Motivation
- Problem Solving
- Attention to Detail
- Advanced knowledge in Darwin Laboratory Information Management Systems (LIMS)
- Extensive knowledge of Microsoft Excel for data analysis and discrepancy resolution
- Teaching and mentoring
- Chromatography techniques
- Scientific presentations
Certification
- Puerto Rico Chemist License (#5390)
- Pharmacology and Therapeutics Certification (2025)
- ASQ Six Sigma Green Belt Training
- HACCP Certification (2010)
- OSHA: 40 Hours Outreach Training (2010)
- Certification in Root Cause Analysis tools and CAPA investigations (2012)
Timeline
Quality Control Laboratory Senior Chemist (Hybrid Remote)
Lilly del Caribe Inc.
12.2021 - 01.2026
Research Analyst
Eli Lilly and Company
08.2017 - 09.2017
Quality Control Laboratory Chemist (Hybrid Remote)
Lilly del Caribe Inc.
06.2012 - 11.2021
Quality Assurance Specialist
Genetech Biomedical, Inc.
09.2008 - 06.2012
Bachelor of Natural Science - Chemistry
University of Puerto Rico
Master of Public Health - Environmental Health
University of Puerto Rico